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Vice President, Global CMC Regulatory
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Role
Vice President, Global CMC Regulatory leading global chemistry, manufacturing, and controls regulatory strategy for late-stage oncology programs.
Responsibilitiesdevelop 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
- oncology program experience
- familiarity with expedited pathways
- Japan-specific CMC knowledge
- lifecycle management expertise
- small molecules
- oncology
- late-stage development
- global regulatory interactions
- lifecycle management
- cross-functional leadership
based in Redwood City, CA, onsite; salary range $294K-$367K.
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