Director of Regulatory Affairs CMC

Job Summary

A company is looking for an Associate Director/Director, Regulatory Affairs CMC.

Key Responsibilities

• Develop and execute global CMC regulatory strategies for viral vector-based gene therapy programs
• Lead preparation and submission of CMC sections for regulatory filings and health authority interactions
• Collaborate with cross-functional teams to ensure regulatory alignment and support due diligence activities

Required Qualifications

• Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering)
• 8+ years of experience in regulatory affairs within the biopharmaceutical industry, with 5 years focused on CMC regulatory
• At least 3 years of direct experience with biologics, preferably viral vector-based products
• Demonstrated experience authoring and submitting CMC sections of regulatory filings
• Working knowledge of cGMP manufacturing for viral vectors