Director, Regulatory CMC

Director, Global Regulatory CMC

New Jersey - United States

Seeking a proven leader to join a small Regulatory team as Director of Regulatory CMC to drive the reg strategy development plans for Cell and Gene Therapy programs while overseeing and supporting the growing global regulatory CMC team and all aspects of the programs in advanced products. This is a fast-paced, highly dynamic work environment within a very employee-centric biotech setting. This role is highly visible and will have internal senior management influence as well as act as the primary liaison with agency interactions, external vendors, corporate partners in the development, strategies, operations, and registration initiatives.

Requirements:

• Bachelor of Science degree in Life Sciences or Biology or equivalent required.
• At least 12 years of relevant regulatory industry experience in a biotech/pharmaceutical setting with 7 years of cell and gene therapy experience.
• FDA Regulatory Pathways for AAV and/or Lentiviral Gene Therapy.
• CMC cell and gene therapy development experience.
• Experienced in leading CMC Regulatory strategic activities across all phases of the drug development.
• Experience driving global reg strategy for Lysosomal Storage Disease programs.
• Very clinically knowledgeable and understand regimens, how drugs are used, how to respond, and clinical questions/requests.
• Strong understanding of advanced therapy product development within including multidisciplinary experience.
• Extensive and comprehensive knowledge of the drug development process.
• Experience interfacing and responding to relevant global regulatory authorities specific to GT products.
• Proven experience in global regulatory submissions (EU, UK, US, and RoW), in particular INDs/CTAs, GMO submissions, briefing documents, PIPs/PSPs, orphan designations, and MAA/BLAs.
• Ability to think strategically and critically and evaluate risks to regulatory activities; ability to work effectively within a complex, business-critical, and high-profile development program.

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.