Senior Manager, Regulatory Affairs Labeling

The posting, as Revolution Medicines wrote it

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. Develop recommendations and coordinate review, escalation, and approval of deviations through established governance processes.

Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables.

Vendor Oversight

Define the scope, source documents, content expectations, timelines, and quality standards for outsourced labeling activities; provide clear instructions and ongoing guidance.

Review vendor-prepared documents for accuracy, completenes
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anges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

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Base Pay Salary Range
$150,000 — $189,000 USD

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