The Opportunity:

RevMed is seeking an experienced privacy executive to support RevMed’s business.  The Executive Director, Global Privacy will lead the strategy, development, and execution of the company’s Privacy Program, ensuring all activities are conducted ethically and in accordance with applicable laws, regulations, and industry codes. This attorney will be instrumental in shaping and sustaining a culture of integrity as the company advances and commercializes its oncology pipeline.

The Executive Director, Global Privacy is a senior leader responsible for driving the organization’s global privacy strategy, governance, and compliance framework. This role ensures that all business activities involving personal data are conducted ethically and in compliance with applicable international laws, regulations, and industry standards.

Reporting to the Vice President, Compliance, this role serves as a key advisor to the General Counsel (GC) and other senior executives on global privacy, data protection, and responsible data use, while fostering a culture of privacy-by-design across all business functions worldwide.

The position can be based in the US or Switzerland.

Key responsibilities include:

Strategic Leadership & Governance

• Lead the development and execution of a comprehensive global privacy strategy aligned with business objectives and the broader compliance program.

• Serve as a senior advisor to the General Counsel (GC) and other senior executives on global privacy risks, regulatory developments, and data governance.

• Establish and maintain enterprise-wide global privacy governance frameworks, policies, and standards.

• Design the Global Privacy team structure and operating model leveraging both regional and global resources, support design and implementation of technology-enabled systems and processes for regional adaptation where appropriate and recruit a high-performing team.

• Provide regular updates to the General Counsel and other senior executives on global privacy program performance, risks, and mitigation strategies.

Global Privacy Program Management

• Design, implement, and continuously enhance a global privacy program aligned with international laws and best practices.

• Ensure alignment of the privacy program with the company’s overall compliance framework and enterprise risk management approach.

• Ensure compliance with global privacy and data protection regulations, including GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other applicable international and local laws.

• Oversee Data Privacy Impact Assessments (DPIAs), cross-border data transfer mechanisms, and global risk assessments.

• Monitor and report on privacy metrics, trends, and program effectiveness across regions.

Clinical and Commercialization Data-Driven Activities

• Serve as the primary privacy lead for all clinical trial-related activities, including data collected from clinical sites, investigators, and patients.

• Partner with R&D and clinical teams to ensure compliant handling of sensitive clinical and health data.

• Collaborate with Commercialization teams to advise on processes, controls, and risks related to data-driven activities, including analytics, digital initiatives, and commercialization strategies.

Operational Integration

• Embed privacy-by-design and privacy-by-default principles into systems, products, and business processes globally.

• Partner cross-functionally with Compliance, Legal, IT Security, R&D, HR, and Commercial teams across regions.

• Support global initiatives involving sensitive data, including clinical, digital, and analytics-driven programs.

• Work closely with HR and Information Security (IS) to address employee and internal data privacy matters, including monitoring, investigations, and governance of workforce data.

Risk Management, Investigations & Incident Response

• Lead or oversee global privacy incident response, including breach assessment, notification, and remediation across jurisdictions.

• Lead and/or oversee privacy-related investigations, including internal reviews and regulatory-driven inquiries.

• Collaborate with Compliance and Information Security to ensure consistent global controls and preparedness.

• Identify, assess, and mitigate global privacy risks in alignment with enterprise risk management priorities.

Regulatory & External Engagement, Third-party & Contractual Oversight

• Serve as a key point of contact for global data protection authorities and regulators, in coordination with Compliance and Legal.

• Support global regulatory inquiries, audits, and inspections related to privacy.

• Oversee global privacy due diligence and risk management for third-party vendors and partners.

• Own and maintain privacy-related standards across the organization, including templates and playbooks.

• Review, negotiate, or oversee negotiation of privacy and data protection terms in contracts, including data processing agreements (DPAs), standard contractual clauses (SCCs), and related provisions.

• Ensure consistent and appropriate privacy language across all contractual forms and third-party engagements.

Training, Culture & Awareness

• Develop and deliver global privacy training and awareness programs aligned with compliance initiatives.

• Promote a culture of privacy, ethics, and accountability across all geographies.

• Partner with Compliance to integrate privacy into Code of Conduct, global policies, and enterprise training programs.

Required Skills, Experience and Education:

• Juris Doctor (JD); active bar membership a plus.

• Privacy certifications (e.g., CIPP/E, CIPP/US, CIPM, CIPT).

• 15+ years of experience in privacy, data protection, legal, compliance, or risk management

• Significant experience managing or leading global privacy programs in multi-jurisdictional environments.

• Experience in regulated industries (e.g., biotech, pharmaceutical, healthcare, or technology) preferred.

• Deep knowledge of global privacy regulations and frameworks (e.g., GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other international laws).

• Experience with cross-border data transfers, data localization requirements, and global data governance.

• Strong understanding of privacy risk assessments, data lifecycle management, and compliance program integration.

• Familiarity with emerging areas such as AI/ML governance, digital health, and global data strategy.

• Ability to influence senior leadership and drive global, cross-functional initiatives.

• Strong strategic thinking with practical, business-oriented judgment.

• Excellent communication and stakeholder management skills across diverse geographies.

• Proven ability to lead teams and operate effectively in a matrixed, global organization.

• Strong organizational and project management capabilities.

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:

Reporting to the VP, GM, Midsized Markets, the Senior Director, Medical Affairs, Midsize Markets Europe, is the medical leader responsible for defining and executing the medical strategy for oncology products in our portfolio within Midsized markets. This role serves as the medical voice within the Midsized markets Leadership Team, ensuring scientific excellence, compliant medical engagement, and strong alignment between global strategy and local patient, physician, and healthcare system needs. This leader will ensure that Midsized markets medical considerations are embedded in the regional medical strategy and plans and will partner with the Midsized markets country managers and crossfunctional teams, as well as VP Head of Europe Medical Affairs and their leadership team. The incumbent will contribute to building the Midsized markets medical team and working closely with the Global, Regional, Country Medical Affairs teams across Med Affairs functions.

Responsibilities:

• Act as the Medical lead for Midsized Markets, accountable for medical strategy, execution, and impact across the RevMed portfolio.

• Serve as a core member of the Midsized Markets Leadership Team, contributing insights to medical and clinical development strategy, launch planning, and business decisions.

• Establish Midsized markets medical strategy across pre-launch, launch, and post-launch phases.

• Oversee all aspects of medical strategy and execution in Midsized markets.

• Cross-functionally align efforts seamlessly with access, regulatory, and commercial objectives while building and executing upon the medical plan.

• Collaborate effectively with regional and global teams by contributing to overall medical strategy, strongly partnering with local, regional and global clinical development and operations teams.

• Translate global medical and clinical strategies into relevant medical strategy.

• Represent the company as the senior medical expert within the local oncology and scientific community, acting as a spokesperson for Midsized markets.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions.

• Build strong relationships with national key opinion leaders, oncology networks, academic institutions, and scientific societies.

• Lead scientific exchange, advisory boards, investigator and other external meetings, press conferences, and congress engagement at country level.

• Provide medical leadership on evidence generation activities including local studies, real-world evidence initiatives, and investigator-initiated research (where permitted).

• Ensure effective execution of publication plans and scientific communication activities.

• Lead medical launch readiness for oncology products, including training, scientific materials, and field medical engagement plans.

• Partner with Market Access and Commercial country and regional teams to support value communication and reimbursement-related interactions from a medical perspective, e.g. representing and defining evidence and value of innovation at oral HTA hearings.

• Support lifecycle management activities including new indications, label updates, and competitive positioning.

• Provide medical review and approval of non-promotional materials in accordance with local regulations and company policies.

• Help recruit country Medical teams, including Medical Directors and Medical Science Liaisons.

• Establish medical processes, governance, and ways of working as part of the Midsized markets build-out.

• Foster a culture of scientific rigor, compliance, and collaboration.

• Ensure all medical activities comply with local regulations, national and EFPIA codes, and internal company policies.

• Represent Midsized markets Medical Affairs in company governance and risk management forums.

Required Skills, Experience and Education:

• Advanced degree required (MD or PhD).

• Strong background and experience in oncology required.

• 10+ years’ experience in Medical Affairs with a track record of country leadership.

• Experience with scientific data generation, clinical trial interpretation, and communication of complex data to diverse audiences.

• Proven value and benefit assessment experience, with deep understanding of midsized markets access, local healthcare systems and regulatory landscape.

• Strong stakeholder management and ability to collaborate with internal and external partners.

• Proven experience supporting oncology product launches in a European market.

• Experience in biotech.

• Excellent communication skills, both in person and virtual.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial environment.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Scientific and solution-orientated mindset and capability to move and execute in a rapidly changing, ambiguous environment.

• Strong understanding of local healthcare systems, customer dynamics, and reimbursement environment.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills. Thrives in a fast-paced, dynamic small company environment and able to adjust priorities and workload based upon changing needs.

• Willingness to travel nationally and internationally.

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-Remote #LI-LO1

The Opportunity:

The Associate Director, People Operations, Europe will play a critical, hands-on role in building and scaling the HR operational infrastructure across Europe. This role will drive the implementation of core HR operations in close partnership with Finance, global People/HR functions, and external vendors, with an immediate focus on establishing payroll and benefits frameworks across multiple countries.

This position requires a highly collaborative operator who can lead execution while navigating a global, matrixed environment, ensuring that regional needs are effectively represented while aligning with global standards.

Key Responsibilities include:

Build & Implement HR Operations Infrastructure

• Drive the design and implementation of end-to-end HR operational processes across Europe (onboarding, offboarding, employee data management, lifecycle workflows) in partnership with global People/HR functions and Finance.

• Partner cross-functionally to ensure alignment of regional processes with global standards, while adapting to local requirements.

• Lead operational readiness for new country expansions, coordinating closely with Finance, Legal, and global teams.

Payroll & Benefits Implementation

• Drive the implementation of payroll infrastructure across multiple European countries in close partnership with Finance and global HR/People functions.

• Lead the setup and operationalization of payroll processes, ensuring alignment across Finance, external vendors, and internal stakeholders.

• Support the implementation and drive the excellence of country-specific benefits programs in collaboration with global Total Rewards, Finance, and external brokers.

• Ensure effective coordination between payroll, benefits, Finance, and global teams to enable accurate and compliant going operations.

• Serve as a key regional point of contact, ensuring alignment between vendors and internal stakeholders.

Compliance & Local Setup

• Drive implementation of compliant HR operational frameworks across countries, in partnership with Legal, Finance, and global HR.

• Coordinate with cross-functional teams and external advisors to support entity setup, employment structures, and regulatory requirements.

• Ensure documentation, contracts, and employee records processes meet both local and global standards.

Systems & Technology (HRIS & TA Systems)

• Partner with global HRIS and Talent Acquisition teams on the implementation and rollout of Workday (HRIS) and Greenhouse (ATS) across Europe.

• Drive regional execution and readiness for system deployments, ensuring alignment with global implementation timelines and milestones.

• Collaborate closely with global system owners to ensure European country-specific requirements (e.g., local regulations, data fields, workflows) are understood, prioritized, and incorporated into system design where appropriate.

• Act as the regional subject matter expert, providing input into configuration decisions while not directly owning system configuration.

• Coordinate user acceptance testing (UAT), data validation, and go-live readiness activities for European markets in partnership with global teams.

• Ensure effective adoption of systems across the region through clear processes, documentation, and stakeholder alignment.

• Partner cross-functionally (HR, TA, Finance, IT) to ensure systems support compliant and efficient end-to-end processes.

Cross-Functional Collaboration & Execution

• Act as a central connector across Finance, Legal, IT, global HR/People Operations functions, and regional stakeholders to drive execution of HR operations.

• Ensure clear ownership, alignment, and communication across all stakeholders involved in European expansion efforts.

• Proactively identify and resolve gaps or dependencies across functions to enable smooth implementation.

What Success Looks Like

• Payroll and benefits infrastructure successfully implemented across European entities through strong cross-functional partnership.

• HR operational processes established and aligned with global frameworks while meeting local requirements.

• Effective collaboration across Finance, Legal, IT, and global HR functions enabling smooth regional expansion.

• Scalable, compliant operations supporting continued growth in Europe.

Required Skills, Experience and Education:

• Bachelor’s degree in human resources, Business Administration, or related field (Master’s preferred).

• Proven experience driving implementation of HR operations and payroll/benefits infrastructure across multiple European countries.

• Profound knowledge of labor law and practical understanding of broader European employment practices.

• Experience working in highly cross-functional, matrixed environments with global stakeholders.

• Hands-on experience in fast-growing or scaling organizations; build-phase experience strongly preferred.

Preferred Skills:

• Team player leading with high standards.

• Strong execution focus with the ability to drive initiatives through cross-functional collaboration.

• Excellent stakeholder management and influencing skills across functions and geographies.

• Ability to operate effectively in a global, matrixed organization.

• Strong project management skills with experience leading multi-country implementations.

• Detail-oriented with a strong focus on accuracy and compliance.

• Fluent in English; additional languages are a plus.

Business Travel Expectation:

• Willingness and ability to travel internationally, as required.

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-Remote #LI-LO1

The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its 2025 Design Award winner for Inclusivity.  

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

The responsibilities of our Platform team include building and maintaining all backend services, including, but not limited to, payments, analytics, subscriptions, new products, text to speech, and external APIs.

This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, is passionate about making product decisions, and has experience building great user experiences that delight users.

We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. 

Our interview process involves several technical interviews and we aim to complete them within 1 week. 

What You’ll Do

• Design, develop, and maintain robust APIs including public TTS API, internal APIs like Payment, Subscription, Auth and Consumption Tracking, ensuring they meet business and scalability requirements
• Oversee the full backend API landscape, enhancing and optimizing for performance and maintainability
• Collaborate on B2B solutions, focusing on customization and integration needs for enterprise clients
• Work closely with cross-functional teams to align backend architecture with overall product strategy and user experience

An Ideal Candidate Should Have

• Proven experience in backend development: TS/Node (required)
• Direct experience with GCP and knowledge of AWS, Azure, or other cloud providers
• Efficiency in ideation and implementation, prioritizing tasks based on urgency and impact
• Preferred: Experience with Docker and containerized deployments
• Preferred: Proficiency in deploying high availability applications on Kubernetes

What We Offer

• A dynamic environment where your contributions shape the company and its products
• A team that values innovation, intuition, and drive
• Autonomy, fostering focus and creativity
• The opportunity to have a significant impact in a revolutionary industry
• Competitive compensation, a welcoming atmosphere, and a commitment to an exceptional asynchronous work culture
• The privilege of working on a product that changes lives, particularly for those with learning differences like dyslexia, ADD, and more
• An active role at the intersection of artificial intelligence and audio – a rapidly evolving tech domain

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The Opportunity:

Reporting to the Vice President, General Manager, Mid-Sized Markets of Europe, the Country Manager, Switzerland will lead the expansion efforts critical to maximizing the opportunity for Revolution Medicines (RevMed) innovation to help patients. In collaboration with the regional leadership team, the successful catalytic leader will develop and execute commercial and operational strategy to accelerate the engagement with key stakeholders and customers (government authorities, regulatory authorities, payer authorities, KOLs) in Switzerland as well as all necessary constituencies to support expansion into the European region - ensuring that reimbursement and access considerations are integrated in the existing and future clinical program design of the company portfolio / pipeline. The incumbent will be responsible for developing pre-launch and commercialization strategic plans for Switzerland and providing Swiss-specific input into lifecycle plans across the RevMed portfolio.  This individual will have full accountability for the Switzerland P&L, all Switzerland operations and will ensure official, fiduciary, corporate, legal and compliance requirements are met locally and for the European region respectively. 

Responsibilities:

• Develop and execute comprehensive plans for the company’s expansion in Switzerland.

• Develop and manage the Switzerland P&L including the budget for operations, ensuring optimal resource allocation.

• As dictated by the commercialization strategy, build and lead the required multifunctional management team, working with corporate functional leaders to ensure that each team member and business function execute against the clear and well-aligned business objectives.

• Lead the planning and execution of product launches in Switzerland, including PEL, market access strategies, pricing, medical affairs atrategy, disease area and marketing strategy, and where appropriate, early access programs.

• Lead the Swiss Government/Corporate Affairs efforts ensuring the successful execution of global and European strategies, advocating for policies that promote patient access. Cultivate and maintain strategic relationships with government entities, patient organizations, healthcare providers, industry associations, and medical societies through innovative engagement programs.

• Represent the company in Swiss healthcare policy forums and industry associations, collaborate with peers to shape collective positions and advocate for patient centered policies.

• Evaluate the competitive environment and understand the profile of portfolio compounds and the patients to serve to identify opportunities and challenges in the oncology market across Europe and other key markets.

• Set key launch and financial performance metrics including revenue, profitability etc.

• Provide Switzerland input for Mid-Sized Markets, Regional and Global Clinical Development Plans.

• Support the Clinical Operations team by ensuring appropriate Swiss site selection, quality and enrollment in-line with regulatory/compliance requirements.

• Co-lead with Finance, Legal, and Commercial, the selection and contract negotiation with any local distributor and Trade 3^rd parties and upon completion of contract, oversee and be accountable for successful execution and achievement of goals by the distributor.

• Support the effective negotiation of consultant/agency contracts for timely and cost-effective services in various business areas to support pre-launch and launch activities.

• Foster a culture within the Mid-Sized markets leadership team, regional and global team consistent with the global RevMed values and vision/mission.

• Build, lead, and develop the country organization, including medical, access, sales, marketing, and customer-facing roles as the business scales.

• Establish commercial processes, governance, and ways of working as part of the country build-out.

• Foster a culture of accountability, collaboration, and performance excellence.

• Establish country governance, risk management, and compliance framework and SOPs.

• Ensure all activities comply with local regulations, industry codes, and internal company policies.

Required Skills, Experience and Education:

• Advanced degree in life sciences, business administration, or a related field.

• Minimum 15 years of proven experience in leadership roles within the biopharmaceutical industry in the field of oncology.

• In-depth knowledge of the Swiss pharmaceutical market, access, pricing and regulatory environment.

• Organizational and P&L leadership experience in Switzerland required.

• Proven track record shaping and executing country strategy and influencing policy at a senior industry level.

• Proven experience building and developing a high performing cross-functional team is a must.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial commercial environment.

• In depth knowledge of Swissmedic, approval and early access mechanisms of medicinal products in Switzerland.

• Fluency in both verbal and written English and German; French and/or Italian is an advantage.

• Ability to create and nurture a strong culture of collaboration and authenticity to extend and replicate the RevMed culture.

• Proven success in building effective relationships with internal stakeholders, regional authorities, and vendors.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills.

• Strong leadership and influencing skills with the ability to create a clear sense of direction.

• Thrives in a fast-paced, dynamic small company environment and able to roll out the sleeves to get things done.

Preferred Skills:

• Experience with an oncology launch in Switzerland is desired.

• Serve as business partners to Development and Clinical Operations functions.

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-LO1 #LI-Hybrid

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:

As part of our expanding European organization, we seek a strategic and hands-on Director, CMC Regulatory, Europe who will be responsible for developing and executing regional CMC regulatory strategies to support early development, marketing authorizations, and lifecycle management across Europe.

This role is responsible for ensuring successful interactions with the European Medicines Agency (EMA), national competent authorities (NCAs), and other regional regulatory bodies. It provides leadership across early- and late-stage CMC regulatory activities, including clinical trial applications, initial marketing authorization applications (MAA), post-approval variations, and lifecycle strategy.

The position requires deep expertise in EU regulatory frameworks, strong cross-functional collaboration, and the ability to proactively identify and manage regulatory risks while supporting business objectives.

Primary Responsibilities:

• Provide CMC regulatory support for clinical trial applications and regulatory interactions, ensuring alignment with EU requirements and timelines.

• Develop and lead execution of European CMC regulatory strategies to support initial marketing authorizations and lifecycle management of the company’s product portfolio.

• Oversee preparation, review, and submission of high-quality CMC dossiers for EU MAAs, variations, renewals, and line extensions.

• Serve as the primary CMC regulatory lead for Europe, managing interactions with EMA, NCAs, and other European regulatory bodies.

• Provide strategic input into global regulatory strategies, ensuring alignment while addressing EU-specific requirements and expectations.

• Assess regulatory impact of CMC changes and provide proactive, risk-based guidance to ensure compliance with EU regulations.

• Interpret and apply EU regulatory requirements (EMA, ICH, EU GMP, and national guidance) to support efficient regulatory pathways, ensure compliance, and proactively monitor and communicate evolving regulatory expectations across functions.

• Anticipate regulatory risks and develop mitigation strategies aligned with European approval timelines.

• Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners to ensure consistent and compliant execution of submissions.

• Represent CMC regulatory on European or global cross-functional teams, ensuring alignment between global strategy and regional execution.

• Provide leadership, mentorship, and technical guidance to team members and contribute to building regional CMC regulatory expertise.

• Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline. An advanced degree (PhD, PharmD, MSc) is desirable.

• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years in CMC regulatory affairs with European focus.

• Strong expertise in EU CMC regulatory requirements, including MAAs, variations, and lifecycle management.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities

• Demonstrated experience supporting EMA submissions and interactions.

• Deep knowledge of EU GMP regulations and ICH guidelines, with ability to apply across the product lifecycle.

• Experience with small molecules (NCEs) and managing complex CMC technical documentation.

• Proven ability to lead regulatory strategy for European approvals within global development programs.

• Strong leadership and project management skills with ability to manage multiple complex programs.

• Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

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-Remote #LI-LO1