Director, Regulatory Affairs Labeling

12+ years in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas.

Experience negotiating with internal stakeholders and regulatory authorities on complex labeling issues.

10+ years in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas.

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Revolution Medicines is seeking a Director, Regulatory Affairs Labeling, who will drive cross-functional development and execution of global regulatory labeling strategy for pipeline, late stage, and marketed products.

This individual will manage regulatory labeling through all phases of development and post-approval, ensuring that the latest requirements and standards are met.

This is an opportunity to join a growing regulatory organization and provide a direct impact on new label development and process initiatives at Revolution Medicines.

Collaborate cross-functionally to develop labeling strategy.

Manage development, review, and approval of high-quality labeling, including Target Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements.

Lead cross-functional Labeling Working Group and Senior Labeling Committee meetings.