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