Director, Regulatory Affairs – Europe

About the role

Revolution Medicines is seeking a strategic, hands‑on Director of Regulatory Affairs for Europe to lead the development and execution of regulatory strategies for its oncology pipeline. Reporting to the Senior Director, Regulatory Affairs, Europe, the role will drive end‑to‑end MAA filings across the EU, EEA, UK and Switzerland and serve as the primary liaison with European health authorities.

Key responsibilities

• Develop and execute European regulatory pathways for Marketing Authorisation Applications and lifecycle management.
• Lead integrated filing plans, coordinate dossier readiness, and secure cross‑functional alignment.
• Act as the main regulatory contact with EMA, national agencies, MHRA and Swissmedic, managing all interactions and communications.
• Prepare and review key submissions such as Scientific Advice packages, Orphan Designation applications and Paediatric Investigation Plans.
• Identify and mitigate regulatory risks, communicating progress and issues to senior leadership.
• Partner with global regulatory leads to ensure alignment of regional and global strategies.

Required profile

• Advanced degree in biological or life sciences, pharmacy, medicine or related field (PhD, PharmD or MSc preferred).
• Minimum 10 years in pharma/biotech with at least 8 years in regulatory affairs, including senior regulatory strategy experience.
• Extensive experience with oncology drug development and successful EMA/MHRA submissions.
• Proven track record in managing large, complex regulatory dossiers and interacting with European agencies.
• Strong leadership, stakeholder management and communication skills.