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.
Our client is located in the greater San Francisco Bay area and as they expect this person to be on site 2+ days/week interested candidates must be able/willing to relocate accordingly.
- 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
