Regulatory CMC Director

Job Summary

A company is looking for a Director/Sr. Director Regulatory CMC to lead regulatory strategies for gene therapy programs.

Key Responsibilities

• Develop and implement global regulatory CMC strategies for gene therapy programs
• Lead the preparation and review of CMC sections for regulatory submissions
• Act as the primary regulatory CMC liaison with health authorities for gene therapy projects

Required Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred
• 5+ years of experience in regulatory CMC for gene therapy or ATMPs
• 5+ years of experience with global regulatory submissions and health authority interactions
• In-depth knowledge of global regulatory requirements for biologics and ATMPs
• Strong scientific understanding of gene therapy technologies and manufacturing processes