The Opportunity:

• Manage planning, preparation (including authoring when appropriate), coordination, and submission of regulatory documents to global National Health Authorities that meet ICH and FDA standards, and other local or regional regulatory requirements.

• Such submissions may include Clinical and Preclinical content. 

• Assist and keep detailed timelines for regulatory activities and submissions. 

• Perform regulatory research to assess regulatory implications and inform business strategy for drug development and approval.

• Assess and communicate risks. 

• Ensure that there are no significant interruptions to the business due to regulatory compliance issues. 

• Correspond and collaborate across the organization at all levels, across functional groups, and with executive management. 

• Support NDA filing activities and assist with developing regulatory process supporting the filing. 

• Prepare and manage routine submissions and related activities. 

• Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations. 

• Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.

Required Skills, Experience and Education:

• Bachelor’s degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields.  

• Three (3) years of experience in Regulatory Affairs department at a drug or biologics company.  

• Employer will accept a Master's degree or equivalent in Regulatory Science or related degree in Life Science or Health Science fields and one (1) year of experience in Regulatory Affairs department at a drug or biologics company.

• Work experience to include:

• Manage the preparation and submission of initial IND (Investigational New Drug) application and subsequent amendments;

• Manage the development of regulatory submissions in eCTD (electronic Common Technical Document) format;

• Interpret and apply FDA (Food and Drug Administration), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), EMA (European Medicines Agency), or PMDA (Pharmaceuticals and Medical Devices Agency) regulations to oncology drug development;

• Manage global regulatory health authority filings and subsequent amendments.

• Successful completion of background checks and employment history verification required.  

• 100% remote position reporting to Revolution Medicines, Inc. in Redwood City, CA.  Candidate may live anywhere in the continental U.S.

The Opportunity:

The Vice President, Regulatory Affairs will manage several key U.S. based regulatory functions and report to the SVP of Regulatory and Quality. The position is responsible for expanding and leading a large, high functioning regulatory group and ensuring global alignment.

• Provide ethical and mission-driven leadership of the Regulatory Affairs functions. Embody and practice the company’s mission-driven culture. Ensure that our core values guide our strategic vision and our day-to-day decision making.

• Provide a vision for the Regulatory Affairs organization and develop a plan to achieve it. Design and rapidly scale a group to meets the needs of an explosive pipeline in areas of high unmet medical need and intense industry competition.

• Influence decision-making of senior leadership and ensure globally aligned regulatory decision-making.

• Collaborate closely and form effective relationships with other functional heads and regional counterparts to ensure high quality, cross-functionally sound decision-making.

• Collaborate with peer leaders and management to ensure regulatory considerations are integrated upstream appropriately, e.g., target product profiles, clinical development plans, financial planning.

• Ensure consistency in approach (one playbook) and that learning occurs across staff and disciplines.

• Continue to build the Regulatory Affairs group, strategizing with other leaders to maximize enterprise-wide impact locally and globally.

• Actively lead the function and support team member career development.

Required Skills, Experience and Education: 

• Local to San Francisco Bay Area or able to travel to headquarters frequently and for adequate durations (up to 25%).

• BA/BS degree in life sciences or related disciplines.

• At least 15 years of experience in drug development regulatory affairs.

• Minimum of 10 years of experience in regulatory leadership or executive role.

• Significant oncology experience.

• Expertise in navigating global regulatory environments in a commercial setting.

• Ability to successfully work in a fast-paced, demanding and highly cross-functional environment.

• Experience scaling an organization rapidly.

• Clearly understands the role of regulatory science in drug development and global commercialization, and is comfortable with ambiguity, risk, and optimizing for business needs.

Preferred Skills:

• Advanced degree in life sciences enabling technical fluency in oncology.

• Prior senior regulatory executive in oncology drug development at a medium or large pharmaceutical enterprise but who also understands the startup environment.

#LI-Hybrid  #LI-GL1 

The Opportunity:

The Associate Director, Regulatory Operations, Europe will play a key role in supporting the growing European Regulatory Affairs organization by leading the operational planning and execution of regulatory submissions across the region. This role partners closely with the European Regulatory Affairs team to operationalize regional regulatory strategies and ensure successful execution of regulatory submissions to health authorities across the EU, EEA, UK and Switzerland.

Working cross-functionally with regulatory strategy, clinical, CMC, nonclinical, and quality teams, the Associate Director will drive submission planning, manage regulatory documentation, and coordinate cross-functional teams to deliver high-quality submissions in accordance with global and regional regulatory operations processes and systems. While primarily focused on the European region, this role operates within Global Regulatory Operations and may support regulatory submissions in other regions as business needs evolve.

Primary Responsibilities:

• Serve as the primary Regulatory Operations partner supporting the European Regulatory Affairs team to execute regional regulatory strategies.

• Lead operational planning, preparation, publishing, and submission of regulatory dossiers to European health authorities including EMA, EU/EEA national authorities, MHRA, and Swissmedic.

• Lead regulatory submission planning and operational execution for major regulatory applications including Marketing Authorisation Applications (MAA), ensuring effective coordination of submission timelines, dossier assembly, publishing, and submission readiness.

• Develop and manage detailed regulatory submission timelines, proactively driving cross-functional teams to ensure timely preparation, review, and delivery of submission components.

• Coordinate cross-functional activities required for regulatory submissions, including document preparation, review cycles, and final submission readiness.

• Publish and perform quality control of regulatory submissions in eCTD format using DocuBridge, ensuring compliance with applicable regulatory technical requirements.

• Manage regulatory submission content and metadata within Veeva Vault RIM, ensuring accuracy and completeness of regulatory information and documentation.

• Support preparation and coordination of key regulatory deliverables including Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions.

• Provide operational guidance to cross-functional teams regarding submission requirements, document standards, and regulatory timelines.

• Partner with Global Regulatory Operations to ensure alignment of regional submission processes, systems, and regulatory documentation standards.

• Manage external publishing vendors and consultants supporting regulatory submission activities.

• Provide regulatory operations support for global submissions as needed, collaborating with Global Regulatory Operations colleagues across regions.

• Manage regulatory procedures via EMA IRIS platform, including scientific advice, orphan designation, and other applicable EMA interactions.

• Ensure accuracy, completeness, and consistency of structured regulatory data and metadata across Veeva Vault RIM and European health authority systems (e.g., CTIS, IRIS, eSubmission Gateway).

• Coordinate submission activities across multiple European submission channels and platforms, ensuring alignment of dossier content and data across eCTD and portal-based submissions.

• Lead operational support for EU regulatory lifecycle activities, including variations, renewals, and other post-approval submissions, ensuring compliance with EU procedural requirements.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline.

• 8+ years of experience in regulatory operations, regulatory affairs, or regulatory submission management within the biotechnology or pharmaceutical industry.

• Demonstrated experience preparing and publishing eCTD submissions to global health authorities.

• Strong understanding of European regulatory submission requirements and procedures.

• Hands-on experience using Veeva Vault RIM for regulatory information management.

• Hands-on experience using DocuBridge for regulatory publishing.

• Demonstrated ability to lead regulatory submission timelines and coordinate cross-functional submission deliverables.

• Strong understanding of regulatory document management, publishing standards, and regulatory submission lifecycle processes.

• Proven ability to manage multiple complex regulatory submissions simultaneously while maintaining high quality and compliance.

• Strong organizational, communication, and stakeholder management skills.

• Familiarity with EMA IRIS platform and associated regulatory procedures (e.g., scientific advice, orphan designation).

• Experience managing regulatory data, metadata, and submission tracking across multiple health authority systems and platforms.

Preferred Skills:

• Experience supporting regulatory submissions to European health authorities including EMA, MHRA, Swissmedic, or EU national competent authorities.

• Experience supporting Marketing Authorisation Applications (MAA) or other major marketing applications.

• Experience working in global regulatory teams supporting both regional and global regulatory submissions.

• Oncology or rare disease regulatory experience is considered an advantage.

• Experience managing regulatory publishing vendors or external regulatory consultants.

• Experience working within a growing or evolving regulatory organization.

• Experience navigating EU regulatory procedures (centralised, decentralised, or mutual recognition).

• Familiarity with evolving EU regulatory data standards (e.g., SPOR/IDMP) is a plus.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability. 

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.

• Motivate, mentor and develop direct reports to ensure development and performance.

• Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.

• Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.

• Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.

• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12+ years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Proven success in developing and delivering global regulatory strategies and submissions.

• Demonstrated success in leading health authority interactions and negotiations.

• Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.

• Strong track record in alliance management, coordinating with external development or commercialization partners.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• An advanced degree is desirable.

• Experience with dose optimization in oncology.

• Prior NDA experience is highly preferred.

#LI-Hybrid #LI-JC1

The Opportunity:

The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.  The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA & global filing regulations, current Health Authority thinking, and have strong leadership & problem-solving ability. 

Reports into Regulatory Affairs, Global Filing & Registration

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the EU, UK, Japan and internationally.

• Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.

• Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.

• Coordinate dossier filing and sub-team rosters for management endorsement.

• Lead cross-functional MAA kickoff according to global filing plans and framework.

• Maintain & track an integrated filing plan including regulatory timelines, modular MAA deliverables, critical path activities, in concert with Regulatory Program Management.

• Identify, respond to, and proactively mitigate risks to filing timelines or regulatory outcomes and report progress to senior management.

• Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.

• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

• Motivate, mentor and develop direct reports to ensure development and performance.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.

• Proven success in executing global NDA/MAAs (preparation, submission & approval).

• Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.

• Demonstrated ability to lead Health Authority interactions and negotiations.

• In-depth knowledge of CTD structure and management of dossier components.

• Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.

• Flexibility to support business needs of dynamic registrational programs.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• Prior experience with regulatory filings and strategy in APAC and access consortium countries highly preferred.

• An advanced degree is desirable. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans.  This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs.  The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed.  This position reports to the Senior Director, Global Regulatory Affairs Project Management.

The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives. 

Core Responsibilities:

• Project manage regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.

• Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.

• Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.

• Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level.

• Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.

• Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.

• Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.

• Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.

• Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.

• Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.

• Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education:

• Bachelor’s degree in a life sciences or related discipline; advanced degree preferred.

• 15+ years of pharma / biotech industry experience, including 8-10 years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.

• Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

• In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.

• Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

• Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.

• Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.

• High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Preferred Skills:

• Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.

• Oncology drug development experience.

• Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols). 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global Regulatory Affairs organization and is responsible for translating global regulatory strategies into actionable execution plans.  This role applies advanced project management expertise and operational leadership to guide cross-functional teams, supporting planned and ongoing drug marketing applications across RevMed programs.  The role partners closely with Global Regulatory Science and Global Filing and Registration and contributes to the broader Global Regulatory Affairs function at RevMed.  This position reports to the Senior Director, Global Regulatory Affairs Project Management.

The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs, including the execution of global new drug marketing applications, in alignment with corporate objectives. 

Core Responsibilities:

• Project manages regulatory submissions from initiation through submission, supporting the definition of scope, timelines, prioritization, resource needs, and key deliverables.

• Develop, maintain, and track comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities.

• Partner with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.

• Facilitate Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level

• Partner with Global Filing Leads on planning, resourcing, and execution of new drug marketing applications for global agency submissions, interactions, and approvals.

• Drive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision.

• Coordinate with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions.

• Proactively identify operational risks, gaps, and bottlenecks; propose and implement solutions, including process improvements and outsourcing strategies, as appropriate.

• Build and maintain submission dashboards; communicate status, risks, and mitigation strategies to senior management and key stakeholders.

• Support the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices.

• Champion innovation and operational excellence, identifying opportunities to streamline regulatory project management and enhance submission preparation efficiency and scalability.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.

• 12+ years of pharma / biotech industry experience, including 6-8+ years of regulatory project management experience. Hands-on U.S. drug marketing application experience required.

• Strong working knowledge of global regulatory regulations, guidelines, and submission pathways; familiarity with nonclinical, clinical, and CMC (bio)pharmaceutical development.

• In-depth knowledge of CTD structure and dossier component management, including coordination across cross-functional filing team contributors and senior leadership.

• Exceptional project management skills with proven ability to manage multiple complex programs under compressed timelines in a fast-paced, cross-functional environment that values both speed and quality.

• Excellent communication and interpersonal skills, with demonstrated ability to influence, manage group dynamics, and balance functional, team, and leadership objectives.

• Ability to think both strategically and tactically and present recommendations to senior leadership and key stakeholders.

• High proficiency with project management tools including Smartsheet and Microsoft Project, and familiarity with WBS management, timeline development, and critical path analysis; experience with OnePager, Office Timeline, and Veeva RIM is a plus.

Preferred Skills:

• Experience supporting global regulatory filings including Japan, Canada, and EU / UK submissions.

• Oncology drug development experience.

• Experience with complex oncology clinical trial designs (e.g., combination studies, multi-cohort expansions, basket or umbrella master protocols). 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability. 

• Deliver sound regulatory strategy to program teams.

• Motivate, mentor and develop direct reports.

• Ensure drug development programs are fully resourced for applicable stages of development.

• Anticipate upcoming work; ensure robust and effective regulatory strategy support.

• Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.

• Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs.

• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Demonstrated success in leading regulatory submissions globally.

• Direct experience with oncology drug development.

• Experienced in representing Regulatory on cross functional teams and presenting to senior management. Excellent communicator.

• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Skills:

• An advanced degree is desirable.

• Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred.

• Prior NDA experience is highly preferred. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

• Provide management and leadership of one or more therapeutic areas for late-stage oncology programs.

• Oversee the development of global regulatory therapeutic area and product strategies to drive product development, global registration, , and effective regulatory agency interactions.

• Provide regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies.

• Foster the career development of staff within the therapeutic area and contribute to departmental leadership activities.

• Ensure alignment and consistency across programs within a therapeutic area based on regulatory intel, research, and competitive landscape.

Primary Responsibilities:

• Direct the development of global regulatory strategy from registrational studies to marketing application across one or more therapeutic areas.

• Lead and mentor GRLs/Study Leads in the development of global regulatory strategies, in partnership with regional regulatory leads, including precedence, risk management and contingency planning.

• Partner with regional regulatory leads to incorporate regional regulatory, scientific, clinical, and market insights into integrated disease area and product strategies.

• Communicate to management aligned global regulatory strategy and plans for a therapeutic area to support portfolio and life cycle management.

• Conduct management review and approval of key documents for regulatory submissions and governance communications.

• Contribute to the target product profile and evaluation of probability of regulatory success.

• Monitor, assess and communicate to staff impact of relevant global regulations, guidance, and current regulatory environment.

• Advise on global health authority interactions and participate on core regulatory and cross-functional teams to ensure effective agency interactions.

• Provide managerial leadership & direction to staff within the therapeutic area, allowing appropriate prioritization of resources to achieve corporate goals.

• Provide coaching, mentoring, and development of staff, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Prior marketing application filing experience. Demonstrated success in obtaining health authority approvals.

• Demonstrated ability in leading teams, establishing organizational direction, and championing continuous improvements.

• Direct experience with global oncology drug development.

• Experienced in representing Regulatory on cross functional teams and presenting to senior management. Proven ability to anticipate challenges and future risks and mitigate against potential strategic issues.

• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Skills:

• An advanced degree is desirable.

• Experience with combination studies, multiple expansion cohort, global registrational studies, basket or umbrella and master protocols highly preferred. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.  The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA regulations, current Health Authority thinking, and have strong leadership & problem-solving ability. 

Reports into Regulatory Affairs, Global Filing & Registration 

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.

• Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.

• Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.

• Coordinate NDA Filing and Sub-team rosters for management endorsement.

• Lead cross-functional NDA kickoff according to global filing plans and framework.

• Maintain & track an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management.

• Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management.

• Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.

• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

• Motivate, mentor and develop direct reports to ensure development and performance.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.

• Proven success in executing US NDAs (preparation, submission & approval).

• Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.

• Demonstrated ability to lead Health Authority interactions and negotiations.

• In-depth knowledge of CTD structure and management of dossier components.

• Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.

• Flexibility to support business needs of dynamic registrational programs.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• An advanced degree is desirable. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.

• Anticipate regulatory needs to deliver on program milestones.

• Develop robust global regulatory strategies that reflect global marketing application filing strategies, expert input, and align with corporate goals to ensure global success.

• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Proven success in developing and delivering global regulatory strategies and submissions, working independently.

• Previous experience with NDA and/or global marketing application filings.

• Previous experience with global ODD annual reports.

• Demonstrated success in leading health authority interactions and negotiations.

• Direct experience in oncology drug development including oversight of large, global Phase 3 studies.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines. 

Preferred Skills:

• An advanced degree is desirable.

• Experience with dose optimization in oncology.

• Prior NDA experience. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.  The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA regulations, current Health Authority thinking, and have strong leadership & problem-solving ability. 

Reports into Regulatory Affairs, Global Filing & Registration 

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US.

• Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.

• Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.

• Coordinate NDA Filing and Sub-team rosters for management endorsement.

• Lead cross-functional NDA kickoff according to global filing plans and framework.

• Maintain & track an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management.

• Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management.

• Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.

• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

• Motivate, mentor and develop direct reports to ensure development and performance.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.

• Proven success in executing US NDAs (preparation, submission & approval)

• Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.

• Demonstrated ability to lead Health Authority interactions and negotiations.

• In-depth knowledge of CTD structure and management of dossier components.

• Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.

• Flexibility to support business needs of dynamic registrational programs.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• An advanced degree is desirable. 

  #LI-Hybrid #LI-JC1

The Opportunity:

Revolution Medicines is seeking a Senior Manager, Commercial Regulatory Affairs to partner closely with the cross-functional teams to ensure that all promotional and medical communication strategies are compliant with applicable regulations, industry standards, and internal policies. This role will help enable successful product commercialization while upholding regulatory integrity and scientific accuracy.

As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

Required Skills, Experience and Education:

• Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.

• Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.

• Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.

• Train and advise cross-functional teams on commercial regulatory compliance, MLR process and best practices.

• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings.

• Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.

• Participate in the development and maintenance of MLR operational objectives, policies, and procedures.

• Bachelor's Degree in a relevant field with 10 years relevant experience.

• 5-7 years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.

• Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews.

• Strong, current understanding of scientific exchange and pre-approval discussions; ability to unpack and deploy these concepts in practice.

• Track record of influencing cross-functional decisions and operating with sound regulatory judgment.

• Excellent communication skills and ability to work collaboratively across teams.

• Collaborative and solution-oriented mindset and approach.

• Exemplary compliance ethics and high concern for standards.

Preferred Skills:

• Advanced degree in a relevant field.

• Experience in oncology therapeutic areas.

• Experience with product launches. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.  The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA & global filing regulations, current Health Authority thinking, and have strong leadership & problem-solving ability. 

Reports into Regulatory Affairs, Global Filing & Registration

• High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the EU, UK, Japan and internationally.

• Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.

• Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.

• Coordinate dossier filing and sub-team rosters for management endorsement.

• Lead cross-functional MAA kickoff according to global filing plans and framework.

• Maintain & track an integrated filing plan including regulatory timelines, modular MAA deliverables, critical path activities, in concert with Regulatory Program Management.

• Identify, respond to, and proactively mitigate risks to filing timelines or regulatory outcomes and report progress to senior management.

• Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.

• Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.

• Motivate, mentor and develop direct reports to ensure development and performance.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.

• Proven success in executing global NDA/MAAs (preparation, submission & approval).

• Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.

• Demonstrated ability to lead Health Authority interactions and negotiations.

• In-depth knowledge of CTD structure and management of dossier components.

• Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.

• Flexibility to support business needs of dynamic registrational programs.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• Prior experience with regulatory filings and strategy in APAC and access consortium countries highly preferred.

• An advanced degree is desirable. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.

• Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.

• Correspond and collaborate with RevMed colleagues and departments to achieve alignment.

• Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.

• Perform regulatory research to inform business strategy. Assess and communicate risks.

• Assure that there are no significant interruptions to the business due to regulatory compliance issues.

• Collaborates across the organization at all levels, across functional groups, and with executive management.

• Develop regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations.

Required Skills, Experience and Education:

• Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience.

• Strong working knowledge of US FDA Pharmaceutical regulations and guidance.

• Proven track record of successful submissions within a regulatory environment.

• Exceptionally strong team player with excellent interpersonal and communication skills.

• Detail-oriented with strong organizational skills and high-quality standards.

Preferred Skills:

• Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.

• Direct experience with IND/NDA filings. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Associate Director, Regulatory Operations Systems role contributes to the development, implementation, and governance of regulatory operation systems. This role serves as the subject matter expert for RIM, regulatory operation infrastructure, driving submission excellence, process optimization, compliance readiness, and system innovation across the Regulatory organization in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology roadmap. Core responsibilities include driving RIM and other RO systems projects across the business, guiding the team through challenges and aligning with the overall business strategy and business development.

• Support and lead activities related to regulatory operation infrastructure and system maintenance, guiding the team through challenges and aligning with the overall business strategy.

• Contributes to the development, implementation, and governance of RIM and publishing system.

• Provides independent leadership and direction on regulatory specifications for RIM systems, working closely with cross-functional teams to achieve shared goals.

• Promotes regulatory information quality, reporting, and development and monitoring of KPIs and metrics to ensure quality.

• Monitor regulatory metadata quality and consistency across the system; identify, investigate, and drive remediation of data quality issues.

• Manages and oversees vendor(s) in relation to RIM supported activities and information management projects, ensuring compliance with regulatory standards while fostering strong partnerships.

• Support inspection readiness activities by ensuring regulatory correspondence and submissions are complete, traceable, and readily retrievable.

• Partner cross-functionally with Regulatory Affairs, Quality, IT, and other stakeholders to continuously improve regulatory archiving and information management processes.

• Contribute to the development and maintenance of SOPs, work instructions, and best practices related to regulatory operations and RIM.

Required Skills, Experience and Education:

• Bachelor’s degree required; advanced degree preferred.

• Minimum of 7–10 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or related functions within the pharmaceutical or biotechnology industry.

• Demonstrated hands-on experience with Veeva Vault RIM, including regulatory document management, metadata usage, and records lifecycle management.

• Strong working knowledge of global regulatory submissions and health authority correspondence processes.

• Proven ability to apply metadata practices in a regulated environment.

• Experience supporting inspection readiness and responding to regulatory or business-critical document requests.

• Strong attention to detail, organizational skills, and ability to manage work independently in a fast-paced environment.

• Excellent written and verbal communication skills, including the ability to train and guide cross-functional stakeholders.

Preferred Skills:

• Prior experience with regulatory submission publishing processes; hands-on publishing experience a plus.

• Experience supporting regulatory due diligence activities for business development, licensing, or mergers and acquisitions.

• Extensive experience in global drug development regulations, regulatory submissions, lifecycle management, and information management processes.

• Experience working in emerging or mid-size biotechnology organizations.

• Experience contributing to process improvement initiatives related to regulatory systems or information management.

• Experience managing vendors and contracts, including overseeing project deliverables and ensuring compliance.

• Ability to work effectively in a matrix structure and complex environments, demonstrating leadership, problem-solving, and flexibility.

  #LI-Hybrid  #LI-SH1

The Opportunity:

You will provide high-level administrative and operational support to the Senior Vice President of Regulatory & Quality and their organization. This role is focused on ensuring efficient execution of day-to-day administrative activities, including scheduling, travel coordination, and event planning. The position requires strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment. Key responsibilities include:

• Managing the SVP’s and their team’s calendars, including scheduling meetings, prioritizing requests, and resolving conflicts.

• Coordinating logistics for internal and external meetings, including scheduling, room reservations, virtual meeting setup, and distribution of materials.

• Supporting Regulatory & Quality team meetings by organizing logistics, tracking attendees, and ensuring smooth execution.

• Planning and coordinating team events, offsites, and internal meetings, including venue selection, catering, materials, and on-site support.

• Coordinating domestic and international travel, including flights, hotels, ground transportation, itineraries, and related logistics.

• Managing expense reports and assisting with budget tracking for travel and team activities.

• Assisting with preparation, formatting, and organization of presentations and documents as requested.

• Supporting hiring and onboarding logistics, including interview scheduling, candidate coordination, and new hire setup.

• Maintaining distribution lists, team calendars, and shared resources.

• Partnering with other administrative staff to coordinate cross-functional meetings and support broader company initiatives.

• Providing general administrative support, including handling ad hoc requests and ensuring timely execution of tasks.

Required Skills, Experience and Education:

• 8–10+ years of administrative experience supporting senior leaders.

• Exceptional organizational and time management skills with strong attention to detail.

• Ability to manage multiple priorities and adapt to changing needs.

• Strong communication skills and professional demeanor.

• High level of discretion in handling confidential information.

• Proactive, reliable, and able to work independently.

Preferred Skills:

• Experience in biotechnology, pharmaceutical, or healthcare environments.

• Advanced proficiency in Microsoft Office (Outlook, PowerPoint, Word, Excel).

• Experience with collaboration tools and travel/expense systems. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Associate Director, Regulatory Operations will serve as a key publishing lead within the Regulatory Operations function, responsible for managing and executing regulatory submission activities to support the company’s growing pipeline and portfolio. This individual will ensure timely, accurate, and compliant submissions to the FDA and other global Health Authorities while contributing to the effective management of regulatory information, systems, and processes that enable operational efficiency and scalability.

This role is an individual contributor with leadership responsibilities, partnering cross-functionally with clinical, quality, CMC, nonclinical, and regulatory strategy teams to ensure seamless document management, publishing, and submission execution. The Associate Director also plays a key role in maintaining the integrity of regulatory information and ensuring compliance with global health authority requirements in a dynamic, fast-paced environment.

Regulatory Publishing & Submission Management

• Oversee the planning, preparation, publishing, submission, and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions.

• Manage submission production and quality control (QC) processes, ensuring compliance with global regulatory requirements and internal standards.

• Provide technical expertise in eCTD publishing tools and platforms (e.g., Veeva Vault RIM) to enable efficient and compliant submission execution.

• Proactively manage publishing timelines from request through archive, anticipating potential issues, escalating risks early, and collaborating with cross-functional teams to adapt plans as needed.

Systems, Tools & Process Optimization

• Support the implementation, optimization, and maintenance of regulatory systems, tools, and technologies to improve submission efficiency and scalability.

• Partner with cross-functional stakeholders to ensure regulatory systems and workflows are well-documented, scalable, and aligned with business needs.

• Drive the development and continuous improvement of SOPs, templates, style guides, and document standards to support compliance and operational efficiency.

• Stay informed on emerging tools, technologies, and industry best practices, identifying opportunities to enhance submission operations and supporting the evaluation and adoption of innovative solutions where appropriate.

Cross-Functional Leadership & Vendor Oversight

• Collaborate with internal stakeholders across clinical, CMC, quality, nonclinical, and regulatory strategy teams to coordinate the creation, review, and approval of regulatory submission documents.

• Manage relationships with publishing vendors and consultants, ensuring appropriate resource allocation and adherence to quality and delivery expectations.

• Provide training and guidance to internal teams on publishing procedures, tools, and best practices to ensure submission readiness.

Strategic Contribution & Compliance

• Communicate complex regulatory and operational issues clearly, providing solutions that balance compliance with the demands of growth and scale.

• Conduct gap analyses of regulatory operations policies, procedures, and SOPs, driving initiatives to enhance departmental efficiency and compliance.

• Maintain current knowledge of regulatory requirements, evolving eCTD guidance, and the broader regulatory operations landscape, providing interpretation and guidance to internal stakeholders.

Required Skills, Experience and Education:

• Bachelor’s degree in a life science, technical, or related field with 8+ years of Regulatory Operations and publishing experience in the biopharmaceutical industry; advanced degree preferred.

• Expert-level proficiency in Microsoft Word, Adobe Acrobat Professional, Toolbox, and StartingPoint.

• Thorough understanding of eCTD publishing standards, submission formatting, transmission, and archiving regulations and guidelines.

• Experience preparing and submitting regulatory dossiers to multiple global Health Authorities; oncology experience is a plus.

• Demonstrated ability to manage and prioritize multiple FDA applications and submissions with overlapping deadlines while maintaining accuracy and compliance.

• Ability to anticipate risks and proactively identify solutions to potential publishing and submission challenges.

• Strong organizational skills with high attention to detail and the ability to work independently in a dynamic, fast-paced environment.

• Proven success collaborating with cross-functional teams and external vendors to deliver high-quality, compliant submissions.

• Excellent interpersonal and communication (written and verbal) skills; able to work effectively across multiple groups, maintaining professionalism, diplomacy, and a positive approach.

Preferred Skills:

• Some experience with people management, such as mentoring, training, or overseeing vendors and consultants.

• Proficiency with Veeva Vault RIM or similar regulatory information management systems.

• Experience using Smartsheet or equivalent project management tools. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

• Support regulatory review activities related to site activation across clinical studies.

• Manage Regulatory Affairs contracts and invoices; maintain and update internal RA tracking tools.

• Archive regulatory documents in accordance with internal procedures and maintain the regulatory query tracker.

• Support regulatory submission workflows in Veeva.

• Co-host Regulatory Sub-Team meetings, including agenda preparation and documentation of action items.

• Participate in RAxROxMW workshops and Regulatory Strategy Forums.

• Conduct weekly one-on-one meetings with the RA Manager to review priorities and progress.

• Build and maintain working knowledge of FDA regulations, guidances, and applicable regulatory requirements.

Required Skills, Experience and Education:

• Currently pursuing a bachelor's degree/MS/PhD in life science, pharmacy, regulatory science, or relevant fields.

• Basic understanding of drug development.

• Attention to detail and organizational skills.

• Must have good verbal and written communication skills.

• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Preferred Skills:

• Familiarity with FDA regulations or global regulatory guidance.

• Prior experience in biotech/pharma or clinical research. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability. 

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.

• Motivate, mentor and develop direct reports to ensure development and performance.

• Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.

• Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.

• Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.

• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 15 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Proven success in developing and delivering global regulatory strategies and submissions.

• Demonstrated success in leading health authority interactions and negotiations.

• Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.

• Strong track record in alliance management, coordinating with external development or commercialization partners.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

Preferred Skills:

• An advanced degree is desirable.

• Experience with dose optimization in oncology.

• Prior NDA experience is highly preferred. 

  #LI-Hybrid #LI-JC1

The Opportunity:

The Senior Director, Head of Early Development Regulatory Affairs will lead global regulatory strategy for early-stage programs (pre-IND through Phase 2) across the portfolio. This leader will shape innovative and efficient regulatory pathways that enable rapid, science-driven development while positioning assets for long-term success.

In addition to strategic leadership, this role will build and scale fit-for-purpose regulatory processes, frameworks, and capabilities to support portfolio growth. The position reports to the Head of Regulatory Sciences and serves as a key member of the Regulatory leadership team.

Primary Responsibilities:

Early Development Strategy

• Lead global regulatory strategy from candidate selection through end-of-Phase 2.

• Shape early clinical development strategy by providing regulatory leadership on dose-finding approaches and indication selection that enable accelerated and differentiated development pathways and position asset for global registration and Health Authority Engagement.

• Oversee strategy and cross functional alignment for global regulatory interactions and briefing documents (Pre-IND, IND, Scientific Advice, Type B/C meetings, PRIME, Sakigake, etc.).

• Translate agency feedback into clear strategic direction, risk identification and risk mitigation plans.

• Build Scalable Regulatory Infrastructure.

• Design and implement fit-for-purpose early development regulatory processes.

• Establish clear governance, decision-making frameworks (e.g., RACI), and documentation standards.

• Drive operational excellence in early regulatory planning, submission readiness, and execution.

• Identify opportunities to streamline workflows and reduce bottlenecks as the organization grows.

Cross-Functional & Portfolio Leadership

• Serve as regulatory representative in early development governance forums.

• Advise senior leadership on regulatory risk, timelines, and probability of success.

• Support business development diligence and integration activities.

Organizational & Talent Development

• Develop and mentor regulatory leaders in early development.

• Build succession depth and technical capability within the function.

• Foster a culture of strategic thinking, accountability, and collaboration.

Required Skills, Experience and Education:

• 8 years of regulatory experience in biotech or pharmaceutical industry required.

• Significant experience leading early development programs (IND-enabling through Phase 2).

• Demonstrated success leading global health authority interactions.

• Experience building or scaling regulatory processes in a growing organization.

• Ability to influence and partner with senior stakeholders.

Preferred Skills:

• 10-12 years of regulatory experience in Biotech/Pharma industry is preferred.

• Experience advising or leading regulatory strategy for basket, umbrella, and platform clinical trials preferred.

• Advanced scientific or clinical degree preferred.

• Demonstrated experience with dose optimization strategies in oncology (Project Optimus) preferred. 

  #LI-Hybrid  #LI-SH1