Director of CMC Regulatory Affairs

Job Summary

A company is looking for an Associate Director/Director, CMC Regulatory Affairs to support global regulatory CMC activities for viral vector-based programs in a remote contract position.

Key Responsibilities

• Support development and execution of CMC regulatory strategies for gene therapy programs
• Author and review CMC sections of regulatory submissions including INDs, CTAs, and amendments
• Collaborate with cross-functional teams to assess manufacturing changes and comparability approaches

Required Qualifications

• MS or PhD in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or a related discipline
• 7-10 years of experience in CMC regulatory affairs supporting biologics or gene therapy programs
• Direct experience contributing to CMC sections of IND or CTA submissions
• Working knowledge of viral vector platforms such as AAV or lentiviral systems
• Strong regulatory writing skills and ability to manage multiple priorities in a fast-paced environment