Director, Regulatory Affairs, Europe

Revolution Medicines · Basel, Switzerland

  • Senior
  • Full-time
  • Posted 2026-08-06
  • Confirmed live on 25 September 2026

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Job description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Director, Regulatory Affairs, Europe who will be responsible for the delivery of regulatory strategy for designated programs at RevMed.

They are accountable for driving preparation & end-to-end execution of regulatory MAA filings across the EU, EEA, UK and Switzerland for oncology programs, ensuring alignment of the European regulatory strategy with the global and regional company`s objectives.

They will independently represent regulatory affairs on global and regional cross-functional teams, delivering targeted, strategic and actionable regulatory guidance for oncology programs across one or more therapeutic areas.

The candidate must have a thorough understanding of oncology drug development, applicable European regulations and is responsible for driving proactive engagement with health authorities including the EMA/MHRA/Swissmedic ensuring successful regulatory outcomes.

The role will report to the Senior Director, Regulatory Affairs, Europe.

Primary Responsibilities:

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Develop, plan and execute regulatory pathways for Marketing Authorisation Applications, and lifecycle management activities in the European Region.

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Develop and execute European regulatory strategies for Marketing Authorisation Applications (MAAs) and lifecycle management activities.

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Lead regional regulatory planning and oversee integrated filing plans, including timelines, deliverables, and critical path activities, in collaboration with Global Regulatory Team.

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Direct and coordinate MAA submissions, including dossier readiness, cross-functional alignment, and governance for management endorsement.

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Serve as the primary regulatory liaison with European health authorities (e.g., EMA and EU/EEA national agencies), leading all interactions and communications.

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Lead preparation and review of key regulatory submissions, including Scientific Advice Briefing Packages, Orphan Designation Applications, and Paediatric Investigation Plans.

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Identify, assess, and proactively mitigate regulatory risks impacting timelines or outcomes; communicate progress and risks to senior leadership.

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Partner with global regulatory leads to ensure alignment between global and regional regulatory strategies.

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Act as a strategic partner to cross-functional teams, including R&D, Medical Affairs, Safety, Market Access, and Commercial.

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Ensure compliance with applicable European regulatory, pharmacovigilance, and governance requirements.

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Monitor and interpret evolving European regulatory requirements, guidelines, and trends, and communicate their impact across functions.

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

Required Skills, Experience and Education:

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Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable.

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A minimum of 10 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.

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Significant experience with oncology drug development highly preferred.

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Deep understanding of European regulatory frameworks and oncology guidelines.

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Demonstrated success in EMA/MHRA submissions and approvals, including but not limited to MAA , Paediatric, Orphan Designations experience.

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

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Experience interacting with the EMA and other European agencies.

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Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.

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Experience in representing Regulatory Affairs on cross-functional teams and presenting to senior management.

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Excellent interpersonal, written, and presentation skills with the ability to effectively communicate complex regulatory strategies to diverse audiences.

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Thrives in fast-paced, dynamic environment and ability to multi-task independentl

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