Director, Regulatory Affairs, Europe
Revolution Medicines · Basel, Switzerland
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Revolution Medicines seeks a Director of Regulatory Affairs to lead European regulatory strategy and execution for oncology programs. The role involves developing marketing authorization applications, managing health authority interactions across EU/EEA/UK/Switzerland, and ensuring alignment between regional and global regulatory strategies.
What they're looking for
- Degree in biological sciences or related field
- Extensive experience in oncology drug development and European regulatory processes
- Demonstrated expertise with EMA, MHRA, Swissmedic, and EU national health authorities
- Strong knowledge of European pharmacovigilance and regulatory compliance requirements
- Experience managing MAA filings and lifecycle management activities
- Proven cross-functional leadership and strategic communication skills
What you'll be doing
- Develop and execute European regulatory pathways for marketing authorizations and lifecycle management
- Lead regional regulatory planning and integrated filing plans with global team coordination
- Direct marketing authorization submissions including dossier preparation and cross-functional alignment
- Serve as primary regulatory liaison with EMA, MHRA, Swissmedic and EU national agencies
- Identify, assess and mitigate regulatory risks impacting program timelines and outcomes
Privacy & handoff
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