Director, Regulatory Affairs Labeling

About this role

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients. The Opportunity: 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. The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel. 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. Maintain expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles. Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.