Director, Regulatory Affairs

Our Gene Therapy client in Cambridge, MA is looking to bring onboard a Director, Regulatory Affairs to their team!  This role will play a critical role in developing and implementing the Regulatory Affairs strategy for their key global programs!   Will represent the Regulatory function on cross-functional product development teams and provide innovative strategic and tactical advice to achieve timely and efficient development and maintenance of programs.  Other responsibilities include but not limited to: 

  • Plan, prepare, and manage global submissions to regulatory authorities including INDs, CTAs, and registrational dossiers.
  • Lead regulatory interactions with health authorities including managing preparation of briefing documents.
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs and senior management, as relevant.
  • Ensure that regulatory documents are accurate, complete and verifiable to confirm compliance with regulatory requirements.
  • Keep abreast of relevant global regulatory requirements and keep the company informed of changes and consequences.
  • Oversee vendor responsibility for regulatory activities and submissions as needed.

Requirements

  • Bachelor’s degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 8+ years’ experience in drug development/regulatory affairs.
  • Experience with both US FDA and EMA is required. Global experience is preferred.
  • Prior BLA and NDA experience is preferred.
  • Experience with the regulation of biologics is essential; experience with gene editing and/or cell and gene therapy preferred.
  • A broad understanding of the drug product development process is required.
  • This position requires a thorough knowledge of U.S. Federal Regulations, ICH Guidance’s, and relevant FDA and EMA guidance’s.
  • Proven experience in critically reviewing detailed scientific information and providing assessment of technical arguments and conclusions based on the data.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.