Director, Regulatory Affairs Labeling

Revolution Medicines seeks a Director of Regulatory Affairs Labeling to develop and execute global regulatory labeling strategy for oncology products across all development phases and post-approval. The role involves managing cross-functional teams, collaborating with regulatory authorities, and ensuring compliance with evolving labeling requirements and standards.

Responsibilities

• Develop and execute global regulatory labeling strategy for pipeline and marketed products
• Lead cross-functional labeling teams and committees through development and approval processes
• Manage creation of target, core, and regional labeling documents per regulatory requirements
• Negotiate labeling changes and regulatory issues with global authorities
• Monitor regulatory environment and assess impact on product labeling activities

Requirements

• Bachelor's degree in science or related discipline
• 12+ years biotech or pharmaceutical industry experience
• Deep expertise in regulatory labeling requirements and guidelines
• Experience managing labeling across multiple regions and regulatory jurisdictions
• Strong cross-functional collaboration and stakeholder management skills
• Quality assurance and proofreading proficiency for regulatory documents