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Regulatory Affairs Director

2 months ago

Redwood City, California, United States HealthCare Recruiters International Full time

**About the Role**

HealthCare Recruiters International is seeking a highly qualified Director of Regulatory Affairs to join our team. As a key member of our R&D team, you will play a critical role in the development and commercialization of innovative robotic systems for the diagnosis and treatment of patients with advanced surgical interventions.

**Key Responsibilities**

  • Lead the preparation of New Drug Application (NDA) activities, collaborating with Contract Research Organizations (CROs) and internal development teams.
  • Develop and execute regulatory plans tailored to the specific needs of small molecule-focused imaging agent drug programs.
  • Take ownership of 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 meeting objectives and briefing materials.
  • Provide overall leadership of the regulatory function, interfacing with the Clinical, Quality Assurance, and CMC teams.

**Requirements**

  • Proven experience in regulatory affairs, with a strong understanding of regulatory requirements and guidelines.
  • Excellent leadership and communication skills, with the ability to interface with cross-functional teams and external consultants.
  • Strong analytical and problem-solving skills, with the ability to develop and execute regulatory plans.
  • Ability to work in a fast-paced environment, with multiple priorities and deadlines.