Vice President, Regulatory Affairs *PC 884
$295,600–$347,764 year
Remote · Waltham, Massachusetts, United States or Gaithersburg, Maryland, United States
Job Summary
Lead regulatory strategy for US Biomedicine programs, overseeing regulatory submissions (NDA/BLA, sBLA) in the US and coordinating with FDA, Health Authorities, and global teams. Independently plan and manage regulatory submissions across clinical and CMC development, post-approval life cycle activities, and regulatory inspection preparation. Develop functional strategies, budgets, and policies for US regulatory affairs; mentor and lead staff; represent US Regulatory Affairs in meetings with Health Authorities and external partners; ensure timely regulatory applications and compliance across programs.
Required Qualifications
- B.S. or higher degree in sciences or health-related field
- 15 years of pharmaceutical/biotechnology regulatory experience with technical management experience
- Extensive experience providing regulatory leadership through the complete clinical and CMC development process
- Proven track record of NDA/BLA submissions and regulatory interactions
- Knowledge of US regulatory processes (FDA), Health Canada, ICH, and global regulations
- Ability to analyze scientific and regulatory documents
- Willingness to travel as required
- ATMP experience is a plus
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