Regulatory Affairs Director

2 weeks ago


Philadelphia, Pennsylvania, United States HealthCare Recruiters International Full time
Director of Regulatory Affairs

Our client, a global leader in the development and commercialization of robotic systems for advanced surgical interventions, seeks a seasoned Director of Regulatory Affairs to support their R&D team.

Located in the greater San Francisco Bay area, this role requires relocation and on-site presence for 2+ days a week.

Key Responsibilities:
  • Lead New Drug Application (NDA) preparation activities in collaboration with CROs and internal development teams.
  • Develop and execute regulatory plans tailored to the specific needs of small molecule-focused imaging agent drug programs.
  • Oversee regulatory submissions through NDA and post-approval commitments, ensuring adherence to regulatory requirements and guidelines.
  • Support End of Phase (EOP) Type B meetings and collaborate with cross-functional teams to develop strategies and briefing materials.
  • Provide leadership of the regulatory function, interfacing with Clinical, Quality Assurance, and CMC teams.

This is an exciting opportunity to join a dynamic team and contribute to the development of innovative robotic systems for patient care.



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