Senior Director Regulatory Affairs
We are looking for a Senior Director of Regulatory Affairs to join an emerging biotech company which recently filed their first NDA and MAA. Reporting to the Senior Vice President of Regulatory Affairs, you will be leading the health agency negotiations in support of their lead cancer and other oncology programs in the pipeline. If you’re ready to jump into a company who will ask you to be on various steering committees as well as influence ADCOM meetings, this type of opportunity would be aligned with your career. This position can be in either their Los Angeles or Bay Area locations. The ideal professional is someone who can jump right in and get their hands dirty!
Responsibilities:
- Serves as the global regulatory lead on the Product Development Team
- Serve as the US regulatory liaison for the assigned clinical studies required to support the assigned indication
- Responsible for development of the global registration strategy to support the assigned indication
- Execution of the global registration plan and management of the global regulatory team
- Submission of the respective NDA/BLA/MAA for assigned product/indications
Knowledge and Skills:
- Minimum BS in a life science required; MS or PhD preferred
- Successful submission, approval, and post-approval management of an NDA/MAA/NDS
- Prior experience as a Global Regulatory Lead responsible for the execution of a global development program in oncology
- Serve as a resource with respect to both strategic and tactical regulatory affairs for one region, including mentoring/coaching manager level
- Excellent communication skills, team player, proven negotiation skills
- Excellent understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the US regulatory environment, project management and medical terminology
- Excellent time and project management skills