Executive Director, Regulatory CMC

Responsibilities
- Define and execute global CMC regulatory strategies for investigational and marketing applications (e.g., IND/CTA/IMPD/MAA/NDA) and lifecycle changes
- Serve as the primary CMC regulatory lead for one or more programs and/or as functional head for Regulatory CMC
- Provide leadership, coaching, and development for Regulatory CMC staff and contractors; build scalable processes as the portfolio grows
- Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests)
- Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.)
- Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks

Qualifications / Requirements
- Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered)
- Typically 12–15+ years of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products—tailor as needed)
- Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred)
- Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks)
- Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment
- Excellent writing, communication, and executive presentation skills
- Demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Role location
- U.S.-based remote role with quarterly (or as needed) visits to the San Francisco office.