Director, Regulatory Operations, Systems

Role: Director of Regulatory Operations, leading and scaling global regulatory information management (RIM) capabilities at Revolution Medicines, with a focus on Veeva Vault RIM platform. Responsibilities: establish RIM strategy, oversee system administration, optimize processes for global regulatory submissions, and drive digital transformation initiatives including automation and AI. Collaborate across functions (Regulatory, Clinical, Quality, IT) to ensure compliance and readiness for structured data standards like IDMP and eCTD 4.0; build and mentor a high-performing team; support inspections and audits. Requirements: Bachelor’s in life sciences, 12+ years in biopharma/medical device, 3–5 years with Veeva RIM, global submission experience (EU, Japan, Canada), leadership experience, strong knowledge of GxP, electronic submissions, and regulatory standards. Preferred: advanced Veeva Vault RIM expertise, oncology development experience, digital transformation background, and cross-regional submission familiarity. HighValue: oncology, RAS-addicted cancers, Veeva Vault RIM, structured data standards, global regulatory submissions (IND through post-market). WorkSetup: based in Redwood City, CA; salary range $211K–$264K USD.