Director, Regulatory Affairs (US Filing Lead)

Role: Lead regulatory strategy and execution for NDA/MAA filings of late-stage oncology programs at Revolution Medicines, focusing on RAS-targeted therapies. Responsibilities: manage end-to-end NDA dossier preparation, coordinate cross-functional teams (Regulatory, Clinical, CMC, Quality, Translational Medicine, Commercial), develop strategic filing plans under expedited pathways, oversee timelines and risk mitigation, lead Health Authority interactions, and mentor team members. Requirements: minimum 12 years in pharma/biotech, with 8+ years in Regulatory Affairs, proven success in US NDA submissions, and extensive experience in oncology drug development, including Phase 3 studies. In-depth knowledge of CTD management, regulatory pathways, and Health Authority negotiations is essential. Preferred: advanced degree. High-Value: US NDA filings, oncology therapeutics, late-stage (Phase 3), global regulatory coordination, and leadership in regulatory strategy. Work setup: onsite in Redwood City, CA, with a salary range of $211K-$264K USD.