VP or Sr. Director of Regulatory Affairs (Cell Therapy)

VP or Sr. Director of Regulatory Affairs (Cell Therapy)

  HireMinds client is seeking to expand their Regulatory Affairs leadership with a crucial hire for cell therapy oversight in 2021. If you are shopping for the right job this Holiday Season don’t miss out on this exciting RA opportunity.  In this role you will develop and guide global regulatory strategy for cell therapy and gene therapy products in a novel portfolio of immunotherapy and regenerative medicine.  You will be the subject matter expert and key lead on all regulatory interactions with agencies and external partners.  You will need to bring a nimble working style and collaborative spirt to a team of experts in cell and gene therapy as well in this unique role. Contact Gabrielle Sacco on the HireMinds Biotech team today to learn more!

In This Role You Will:

  • Have to devise and lead Regulatory strategies and daily operations for a diverse portfolio of cell and gene therapy products
  • You’ll Identify and assess regulatory risks and anticipate mitigation of any perceived gaps in regulatory protocols or policies
  • You will prepare regulatory submissions regarding the cell and gene therapy portfolio with experience in: eCTD and e-publishing systems for preparing regulatory submissions
  • Lead Regulatory agency interaction on all Pre-IND meetings, pre-BLA meetings, Advisory Committee meetings, and presentations  for corresponding meetings
  • Be the primary Point-person on all Regulatory items for the company and build and maintain successful relationships with relevant regulatory agencies stateside and abroad

 

You Are Required To Have:

  • Ph.D., MD or related degree in Regulatory Affairs with 8+ years pharmaceutical/biotechnology industry experience in leading Regulatory Affairs
  • Regulatory program experience with focus preferably in cell therapy regulated products and companion dx space. Will consider candidates with experience in gene therapy or oncology immunotherapy products as well
  • Track record of success in Biotech setting in evolving with an emerging company in the cell therapy or oncology  sector
  • Hands-on experience and interactions with International regulatory bodies including EU and Japan
  • Specific examples of successful preparation of major regulatory submissions and supportive amendments or supplements for early and late stage development programs across R&D and Clinical Development stages of a product lifecycle
  • Solid knowledge of Regulatory SOPs, GMP, and GxP regulations and experience in implementing policies
  • Collaborative ability to effectively communicate and incorporate regulatory strategy with team members in R&D, business development,  manufacturing, and clinical functions