Executive Director, Regulatory CMC

Job Summary

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