Position Type : Full Time
The Office of Clinical Research (OCR), Sponsor Support Unit, together with the Perelman School of Medicine (PSOM) is seeking a Sr. Associate Director of Regulatory Affairs. This position will provide senior leadership and create the regulatory strategy for the PSOMs device portfolio and support those same activities for the IND portfolio. It will provide direction to regulatory and senior regulatory specialists across the Sponsor Support Unit. It is responsible for the supervision, preparation and critical review of high quality regulatory submissions to the FDA and other global Authorities, including IDEs, INDs, 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 2 Associate Directors and the Director of the Sponsor Support Unit to provide direct guidance to new and current IDE, and CTA faculty sponsors in the PSOM and SEAS. It will supervise all staff working on IDE submissions.
This position will be responsible for the planning and direction of regulatory affairs activities for IDEs and INDs; will work directly with Industry partners to achieve alignment of regulatory strategy; will develop and implement strategies with the goal of timely approval of regulatory submissions; will provide leadership and management of the Regulatory Affairs function; will provide training and guidance to new and current IDE Sponsors; will develop and edit Regulatory Affairs PSOM policy and procedures (SOPs) related to IDE; will author (when applicable), review, submit, and maintain IDE, IND, and CTA applications, amendments, safety reports, and annual reports in accordance with established SOPs, timelines, and submission dates; will review all relevant clinical documents to include Pre IND materials, Trial Protocols, Investigator Brochures (IB), Informed Consent Forms, and other supporting documents, data and reports to ensure clarity, consistency, and conformance to regulations, guidelines and regulatory strategy as well as suitability for submission to regulatory agencies; will function as a regulatory representative in discussions with Health Authorities for both device and biologics submissions; prepare and submit regulatory applications; review, evaluate, proofread and compile documents and reports for submission; will monitor and update national and international registration requirements through Health Authority news announcements, reviews of publications, seminars, and direct communication with outside regulatory personnel; will monitor project progress; will prepare and submit reports to senior management, as required; will assist in the development of a regulatory and submission document management system and will maintain regulatory and submission documents to ensure timely and accurate access to and retrieval of such documents.