Job description

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




Diversity Profile: University



View more

Learn more on Inside Higher Ed's College Page for University

Arrow pointing right
Job No:
Posted: 5/18/2017
Application Due: 5/18/2018
Work Type: