Director, CMC Regulatory, Europe

Revolution Medicines seeks a Director, CMC Regulatory, Europe to develop and execute regional CMC regulatory strategies to support early development, marketing authorizations, and lifecycle management across Europe.

Requirements

• Provide CMC regulatory support for clinical trial applications and regulatory interactions
• Develop and lead execution of European CMC regulatory strategies
• Oversee preparation, review, and submission of high-quality CMC dossiers
• Serve as the primary CMC regulatory lead for Europe
• Provide strategic input into global regulatory strategies
• Assess regulatory impact of CMC changes and provide proactive guidance
• Interpret and apply EU regulatory requirements
• Anticipate regulatory risks and develop mitigation strategies
• Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners
• Represent CMC regulatory on European or global cross-functional teams
• Provide leadership, mentorship, and technical guidance to team members
• Oversee external vendors and CROs

Benefits

• Life insurance
• Health insurance
• Paid time off