Director of CMC Regulatory Affairs

Job Summary

A company is looking for a Director, CMC Regulatory Affairs to lead global regulatory strategy in gene therapy and advanced biologics.

Key Responsibilities

• Define and drive global CMC regulatory strategy for gene therapy programs from development through commercialization
• Lead preparation, review, and approval of CMC content for INDs, CTAs, BLAs, MAAs, and post-approval submissions
• Serve as the CMC regulatory lead for interactions with global health authorities, including FDA and EMA meetings

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 for biologics or gene therapies
• Deep understanding of viral vector manufacturing processes and analytical characterization strategies
• Strong leadership and decision-making skills within fast-moving development environments