Director of CMC Regulatory Affairs

Job Summary

A company is looking for an Associate Director/Director, CMC Regulatory Affairs to support a clinical stage biotechnology organization in gene therapy.

Key Responsibilities

• Develop and execute CMC regulatory strategy for viral vector gene therapy programs
• Author and review detailed CMC sections for INDs, amendments, and BLAs
• Act as the primary CMC regulatory subject matter expert and partner with technical teams to assess regulatory risks

Required Qualifications

• Direct experience preparing CMC sections of a gene therapy BLA
• Strong background in viral vector gene therapies, such as AAV or lentiviral platforms
• Experience with US BLA submissions and exposure to Canadian and/or European regulatory pathways
• Proven ability to manage complex CMC regulatory questions and interact with health authorities
• Bachelor's degree in a scientific discipline or equivalent experience; advanced degrees are welcome