Provide strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products
Partner closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.
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.

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
You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.

Executive Director, Regulatory CMC

Key skills