Director, Regulatory Affairs - CMC

3 days ago

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Asklepios BioPharmaceutical, Inc. (AskBio)

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AAV • Adeno-Associated Virus • Gene Therapy • Rare Disease • AAV Manufacturing

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• The Director, Regulatory Affairs CMC is responsible for managing the regulatory CMC strategy and coordinating regulatory operations and logistics for all assigned projects. • This role will assure appropriate development and timely registration of gene therapy product candidates. • Reporting to the Vice President, Regulatory Affairs CMC, the role will be responsible for the progression and submission of regulatory filings for gene therapy projects, in the US and internationally. • The individual will drive the preparation and submission of high‑quality CMC sections of briefing documents, IMPDs, GMOs, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs), in close collaboration with analytical, CMC and Quality teams, contract manufacturing organizations, and external consultants and collaborators.

Requirements

• Bachelor’s Degree in a scientific discipline with a minimum of 10 years of experience in drug development, process or analytical R&D and manufacturing is required with experience in biologics, vaccines, gene or cell therapy. • Equivalent experience on the review/agency side may also be considered. • At least 5 years in a regulatory CMC role and demonstrated increasing level of responsibility • Experience working with cell therapy, gene therapy products or mRNA-based therapeutics • Proven record of contributions to successful IND/CTA and NDA/BLA/MAA submissions and approvals