Director of Regulatory Affairs

2 months ago


San Carlos, United States HealthCare Recruiters International Full time

Our client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small molecule (drug)-imaging agents.


  • Lead New Drug Application (NDA) preparation activities, working in conjunction with CROs/internal development team
  • Devise and execute regulatory plans tailored to the specific needs of the small molecule-focused imaging agent drug program
  • Take ownership for all regulatory submissions through to NDA and post approval commitments, ensuring adherence to regulatory requirements and guidelines and interfacing with external consultants as necessary
  • Support End of Phase (EOP) Type B meetings, collaborate cross-functionally to develop strategies on the meeting objectives and briefing materials
  • Provide overall leadership of the regulatory function, interfacing with the Clinical, Quality Assurance and CMC teams


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