Regulatory Specialist

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Regulatory Specialist

Duties: Uses advanced research compliance skills to interpret highly complex and broad regulations, policies and guidelines, with particular focus on Food and Drug Administration (FDA) regulations. Regularly works on complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems to develop and implement the appropriate response and / or action. Serve as the institution’s subject matter expert on Food and Drug Administration (FDA) regulatory compliance. Maintaining current knowledge of relevant FDA regulations and guidance documents, as well as applicable University policies and standard operating procedures (SOPs) related to research compliance. Providing consultation services to researchers and Institutional Review Board (IRB) staff on matters such as: the likely FDA submission requirements for new research involving drugs, devices, and/or biologics (e.g., IND, exemptions, NSR, 510(k), IDE); obtaining access to unapproved drugs/devices/biologics for clinical care; FDA and institutional recordkeeping requirements; FDA and institutional reporting requirements; Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and other relevant standards; distinguishing research from innovative clinical care (in collaboration with other institutional experts). Assisting with FDA inspections (in collaboration with IRB staff and legal counsel). Participating in process improvement activities. Leading training and outreach efforts to promote compliance with FDA regulations. Other compliance functions may include outreach efforts on topics such as: export control compliance, conflict of interest disclosures, record retention requirements, audit preparation, whistleblower complaints, whistleblower retaliation, and ClinicalTrials.gov registration. Reports to the Chancellor directly; units comprising the Office of Ethics and Compliance are located within the Office of the Executive Vice Chancellor and Provost. The Office of Ethics and Compliance collaborates with the community and senior leadership to coordinate and guide compliance efforts across the campus. Our mission is to ensure institutional compliance with applicable laws and regulations; to promote ethical behavior and research integrity; to provide the tools, guidance, and oversight needed to adhere to all necessary regulatory requirements; and to provide with expertise and support to achieve its mission of advancing health worldwide.

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