Director, Regulatory Affairs (Global Filing Lead)

Role: Lead global regulatory filings for late-stage oncology programs, focusing on NDA/MAA preparation and execution. Responsibilities: develop and manage strategic filing plans for registrational oncology therapies, coordinate cross-functional teams across Clinical, CMC, Quality, and Regulatory departments, lead interactions with Health Authorities, and oversee dossier submission timelines. Requirements: minimum 12 years in pharma/biotech, with 8+ years in Regulatory Affairs including global NDA/MAA strategy and execution; proven success in regulatory filings, strong leadership, and experience with oncology drug development, especially large Phase 3 studies. HighValue: oncology, late-stage (Phase 3), global NDA/MAA filings, Health Authority negotiations, experience with expedited pathways. WorkSetup: based in Redwood City, CA; salary range $211K–$264K; travel expectations not specified.