Revolution Medicines is seeking a Director of CMC Regulatory for its expanding European organization in Basel, Switzerland. The role involves developing and executing CMC regulatory strategies for clinical trials and marketing authorizations, requiring deep expertise in EU regulations and strong leadership skills
Job Summary
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.
The role involves leading interactions with the European Medicines Agency (EMA) and national competent authorities to support product approvals.
Candidates must have deep expertise in EU regulatory frameworks to manage complex CMC technical documentation for small molecules.
Matching Summary
Match Score: 85
Revolution Medicines is seeking a Director of CMC Regulatory for its expanding European organization in Basel, Switzerland. The role involves developing and executing CMC regulatory strategies for clinical trials and marketing authorizations, requiring deep expertise in EU regulations and strong leadership skills.
Skills & Requirements
Must-have
EU CMC regulatory requirements expertise
EMA submission experience
Marketing authorization application preparation
Lifecycle management strategy execution
EU GMP and ICH guidelines knowledge
Nice-to-have
Strategic input into global regulatory strategies
Leadership and mentorship capabilities
Cross-functional collaboration skills
Vendor and CRO management experience
Key Requirements
15 years pharmaceutical/biotech drug development experience
5 years CMC regulatory affairs with European focus
Bachelor's degree in Pharmaceutical Sciences or related field