Director of Regulatory Affairs CMC
Virtual Vocations Inc, New York, NY, United States
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
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