ASSOC DIRECTOR, REGULATORY AFFAIRS
Duties: The Office of Clinical Research (OCR), Sponsor Support Unit, together with the Perelman School of Medicine (PSOM) is seeking an Associate Director of Regulatory Affairs. This position directs the regulatory aspects of the Gene Therapy program, contributes to all Unit activities, is responsible for the supervision, preparation and critical review of high quality regulatory submissions to the FDA and other global authorities, including INDs, IDEs, and CTAs, amendments, annual reports, and safety reporting, overall planning and direction of regulatory activities, and developing and implementing strategies with the goal of prompt approval of regulatory submissions. This position will work in tandem with the Director of the Sponsor Support Unit to provide direct guidance to new and current IND, IDE, and CTA sponsors in the PSOM.
Qualifications: A Master's degree and 5 to 7 years of experience in drug and device development or equivalent combination of education and experience required. Master's degree in Regulatory Affairs preferred. RAC preferred. Direct experience with the FDA required and some experience with Health Canada and EMA member states required. Possess strong communication, management, and organizational skills.
Reference Number: 40-25742
Salary Grade: 029
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: B-Executive/Managerial Administration