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Senior Manager, Regulatory Affairs Labeling

Revolution Medicines
United StatesremoteEnglish150k-189k USD/year3d ago

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: The Senior Manager of Labeling serves as a labeling support strategist, partnering with the Global Labeling Lead to execute global labeling deliverables for assigned products. The role develops and maintains regional labeling using the Company Core Data Sheet (CCDS) or an approved reference regional label, adapting content to applicable local requirements while preserving alignment with global labeling strategy. The Senior Manager prepares labeling documents directly or oversees their preparation by external vendors. In both cases, the individual is accountable for document quality, timely delivery, and management of all required cross-functional review and approval activities through completion, in accordance with company procedures and designated approval authorities. 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. Labeling Development and Strategic Support Partner with the Global Labeling Lead to translate global labeling strategy into actionable regional and country labeling plans, including deliverables, dependencies, timelines, and review requirements. Author, revise, and maintain regional prescribing information and patient labeling, as applicable, using the CCDS or an approved reference regional label and relevant supporting documentation Assess the impact of CCDS changes, reference label updates, new clinical or safety information, and health authority feedback on assigned labeling; coordinate required updates with regional Regulatory Affairs. Identify and document differences between proposed local labeling and the CCDS or reference label....

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