Director, CMC Regulatory – Europe

About the role

Revolution Medicines is seeking a Director of CMC Regulatory for Europe to lead the development and execution of CMC regulatory strategies supporting early‑stage development through to marketing authorisation and product lifecycle management across the European Union.

Key responsibilities

• Provide CMC regulatory support for clinical trial applications and ensure alignment with EU timelines and requirements.
• Develop and implement European CMC regulatory strategies for initial marketing authorisations, variations, renewals and line extensions.
• Lead preparation, review and submission of high‑quality CMC dossiers for EU MAAs and post‑approval changes.
• Serve as the primary liaison with the EMA, national competent authorities and other European regulatory bodies.
• Contribute strategic input to global regulatory plans while addressing EU‑specific expectations.
• Assess regulatory impact of CMC changes and deliver risk‑based guidance to maintain compliance.
• Monitor evolving EU regulatory guidance (EMA, ICH, EU GMP, national) and communicate implications across functions.

Required profile

• Extensive experience in EU CMC regulatory affairs within the pharmaceutical or biotech industry.
• Proven track record of leading CMC submissions for clinical trials and marketing authorisations in Europe.
• Strong ability to collaborate with cross‑functional teams and external partners.
• Excellent communication skills and strategic thinking.

Required skills

• In‑depth knowledge of EMA processes and EU regulatory frameworks.
• Familiarity with ICH guidelines and EU GMP requirements.
• Experience preparing CMC dossiers for MAAs, variations and renewals.
• Risk assessment and mitigation in CMC regulatory contexts.