Seattle, Mass, or New Jersay
about 1 month ago
We have partnered with one of the most exciting Cell & Gene Therapy Biotech’s who are advancing their novel Cell & Gene Therapy platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies to treat a broad array of diseases.
This position is responsible for providing regulatory leadership and guidance to CMC teams developing cell therapy products, including the oversight and generation of quality dossiers to support Health Authority meetings, clinical trial applications and market applications in the U.S. and multiple international territories.
- Working closely with technical CMC teams, project teams, as well as serving as point for interactions with global health authorities
- Provide expertise and knowledge of global regulations and guidance for the development of their cell therapy programs.
- Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from departmental head on complex topics.
- Represent regulatory CMC on and/or lead matrix teams for cell therapy pipeline products.
- Prepare and manage CMC submissions for global markets while ensuring thoroughness, completeness and timeliness.
What is needed from you:
- The ideal candidate should have a strong background in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise in biologics and deep experience in product development.
- At least 7-10 years in Regulatory Affairs, CMC and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products.
- Experience in development, manufacturing and testing of cell therapeutics is highly desirable.
- Experience interfacing with regulatory authorities
- Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA, and NDA/BLA/MAA
- Knowledge and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development
This will be a hybrid role as of right now.