Lead Consultant, Regulatory CMC (Cell & Gene Therapy)
100% Remote - United States
Seeking an experienced Lead CMC Regulatory professional with strong strategic leadership skills and a thorough understanding of global regulatory science in the drug development context. This new hire will serve as the Cell & Gene Therapy SME for all biological studies and submissions and being a key contributor to the development of these novel products. Seeking strong global expertise, along with proven leadership skills with a successful track record of developing and executing strategy while working collaboratively and cross-functionally with the team. Prior hands-on experience leading and developing regulatory development strategies and submissions. You will work closely with the clients and help guide reg activities covering from pre-IND all the way through to commercialization, and post-approval deliverables.
- Bachelor's degree in life sciences or in a Scientific discipline or equivalent required with 10 years of CMC Regulatory in a biopharmaceutical setting (Advanced degree preferred).
- Strong knowledge and working experience in Cell and Gene Therapy.
- Strong knowledge of current regulatory guidance, GxPs, and industry developments.
- IND, NDA, BLA expertise.
- Strong and successful FDA interactions and relations are required. Must be able to handle any FDA requests.
- Experienced in leading CMC Regulatory strategic activities across all phases of the drug development.
- Very clinically knowledgeable and understand regimens, how drugs are used, how to respond, and clinical questions/requests.
- Will be joining the Program Team meetings and strong knowledge of the US FDA, and EU. Understanding EU, and EMA issues and questions.
- Experienced in the Biological product space.
- Experienced in leading the studies and strategies.
- Ability to think strategically and critically and evaluate risks to regulatory activities.
- Ability to work strategically within a complex, business-critical, and high-profile development program.
- Key skills: Strategic thinking & influencing, leadership, initiative, management, communication, negotiation, and presentation skills.
If interested in learning more, please contact Bria Gaber at firstname.lastname@example.org or (646) 430-1191 for more information.