Director of CMC Regulatory Affairs

Job Summary

A company is looking for a Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs in a remote contract position.

Key Responsibilities

• Define and drive global CMC regulatory strategy from development through commercialization
• Lead preparation, review, and approval of CMC content for regulatory submissions
• Serve as the CMC regulatory lead for interactions with global health authorities

Required Qualifications

• MS or PhD in a life science or engineering discipline relevant to biologics development
• 10-15+ years of experience in regulatory affairs with leadership responsibility for CMC strategy
• Proven track record leading CMC regulatory submissions and agency engagements
• Deep understanding of viral vector manufacturing processes
• Strong leadership and decision-making skills within fast-moving development environments