Executive Director, Regulatory CMC

A company is looking for an Executive Director, Regulatory CMC. Key Responsibilities Define and execute global CMC regulatory strategies for investigational and marketing applications Lead preparation, review, and approval of CMC sections for regulatory submissions and manage health authority interactions Provide leadership and development for Regulatory CMC staff and contractors, building scalable processes Required Qualifications Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered) 12-15+ years of relevant experience in CMC regulatory affairs within biotech/pharma Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions Deep knowledge of global CMC regulations and guidances Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment

Created: 2026-03-05