Vice President, Global CMC Regulatory

Role: Vice President, Global CMC Regulatory leading global chemistry, manufacturing, and controls regulatory strategy for late-stage oncology programs. Responsibilities: develop and execute global CMC strategies aligned with product development, lead interactions with health authorities (FDA, EMA, PMDA, NMPA), oversee regulatory submissions and lifecycle management, and collaborate cross-functionally with manufacturing, quality, and development teams. Build and lead a high-performing global CMC regulatory team, manage external consultants, and ensure compliance with international regulatory frameworks. Requirements: PhD, PharmD, or MS in Chemistry or Pharmaceutical Sciences; 18+ years in biotech/pharma, with 10+ years in CMC regulatory affairs and global submissions; proven success in small-molecule CMC regulatory strategies, especially in late-stage biotech/pharma settings. Preferred: oncology program experience, familiarity with expedited pathways, Japan-specific CMC knowledge, and lifecycle management expertise. HighValue: small molecules, oncology, late-stage development, global regulatory interactions, lifecycle management, cross-functional leadership. WorkSetup: based in Redwood City, CA, onsite; salary range $294K-$367K.