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. 

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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. 

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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. 

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