Director, CMC Regulatory, Europe

The company is seeking a Director of CMC Regulatory for Europe to lead regional regulatory strategies, manage interactions with European authorities, and oversee CMC activities from early development through lifecycle management.

Revolution Medicines is expanding its European operations and needs a strategic, hands-on leader to direct CMC regulatory activities across the region. This position will shape and execute regional strategies to support early development, secure marketing authorizations, and manage product lifecycles while ensuring effective engagement with the EMA, national competent authorities, and other European regulatory bodies.

Responsibilities

• Deliver CMC regulatory guidance for clinical trial applications and ensure compliance with EU timelines and standards.
• Create and drive European CMC regulatory strategies to facilitate initial marketing authorizations and ongoing product lifecycle management.
• Manage the preparation, review, and submission of comprehensive CMC dossiers for EU marketing authorizations, variations, renewals, and line extensions.
• Act as the main CMC regulatory contact for Europe, coordinating with the EMA, national competent authorities, and other regional agencies.
• Contribute to global regulatory strategies by incorporating EU-specific requirements and expectations.
• Evaluate the regulatory implications of CMC changes and provide proactive, risk-based advice to maintain EU compliance.
• Apply EU regulatory standards, including EMA, ICH, and EU GMP guidelines, to support efficient regulatory pathways and communicate evolving expectations.
• Identify potential regulatory risks and develop mitigation plans that align with European approval schedules.
• Collaborate with global Regulatory Affairs, Quality, Technical Operations, and external partners to ensure consistent and compliant submission execution.
• Represent CMC regulatory on cross-functional teams to align global strategy with regional execution.
• Provide leadership, mentorship, and technical guidance to team members while building regional CMC regulatory expertise.
• Supervise external vendors and CROs to ensure timely and high-quality regulatory submissions and approvals.

Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific field.
• At least 15 years of experience in pharmaceutical or biotech drug development, including a minimum of 5 years focused on CMC regulatory affairs with a European emphasis.
• Extensive knowledge of EU CMC regulatory requirements, including marketing authorizations, variations, and lifecycle management.
• Hands-on experience preparing and submitting complex regulatory documentation for health agency reviews and post-approval activities.
• Proven track record of supporting EMA submissions and interactions.
• Deep understanding of EU GMP regulations and ICH guidelines, with the ability to apply them across the product lifecycle.
• Experience with small molecules (NCEs) and managing complex CMC technical documentation.
• Demonstrated ability to lead regulatory strategy for European approvals within global development programs.
• Strong leadership and project management skills to handle multiple complex programs.
• Excellent communication and stakeholder management skills, including cross-functional and external partner collaboration.
• Ability to thrive in a fast-paced, matrixed, global environment.

Nice to have

• An advanced degree (PhD, PharmD, MSc) is desirable.

About the company

Revolution Medicines is a late-stage clinical oncology company focused on developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline includes RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. Joining the team means working alongside outstanding professionals dedicated to improving outcomes for patients with cancers harboring mutations in the RAS signaling pathway.

• Late-stage clinical oncology company developing novel targeted therapies for RAS-addicted cancers.
• R&D pipeline features RAS(ON) inhibitors targeting diverse oncogenic variants of RAS proteins.
• Commitment to patients with cancers harboring mutations in the RAS signaling pathway.