Director, Regulatory Affairs, Europe

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS‐addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC‑6236), a RAS(ON) multi‑selective inhibitor; elironrasib (RMC‑6291), a RAS(ON) G12C‑selective inhibitor; zoldonrasib (RMC‑9805), a RAS(ON) G12D‑selective inhibitor; and RMC‑5127, a RAS(ON) G12V‑selective inhibitor, are currently in clinical development.

As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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 Rev Med.

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/Swiss medic ensuring successful regulatory outcomes.

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

• Develop, plan and execute regulatory pathways for Marketing Authorisation Applications, and lifecycle management activities in the European Region.
• Develop and execute European regulatory strategies for Marketing Authorisation Applications (MAAs) and lifecycle management activities.
• Lead regional regulatory planning and oversee integrated filing plans, including timelines, deliverables, and critical path activities, in collaboration with Global Regulatory Team.
• Direct and coordinate MAA submissions, including dossier readiness, cross‑functional alignment, and governance for management endorsement.
• Serve as the primary regulatory liaison with European health authorities (e.g., EMA and EU/EEA national agencies), leading all interactions and communications.
• Lead preparation and review of key regulatory submissions, including Scientific Advice Briefing Packages, Orphan Designation Applications, and Paediatric Investigation Plans.
• Identify, assess, and proactively mitigate regulatory risks impacting timelines or outcomes; communicate progress and risks to senior leadership.
• Partner with global regulatory leads to ensure alignment between global and regional regulatory strategies.
• Act as a strategic partner to cross‑functional teams, including R&D, Medical Affairs, Safety, Market Access, and Commercial.
• Ensure compliance with applicable European regulatory, pharmacovigilance, and governance requirements.
• Monitor and interpret evolving European regulatory requirements, guidelines, and trends, and communicate their impact across functions.
• Oversee external vendors and CROs to ensure timely, high‑quality regulatory submissions and approvals.

• Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable.
• 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.
• Significant experience with oncology drug development highly preferred.
• Deep understanding of European regulatory frameworks and oncology guidelines.
• Demonstrated success in EMA/MHRA submissions and approvals, including but not limited to MAA, Paediatric, Orphan Designations experience.
• Direct hands‑on experience in the preparation and…