Expanded Access Regulatory Specialist

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university of michiganAnn Arbor (MI)

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About the role

University of Michigan is seeking a regulatory professional to support Expanded Access (EA) programs for drugs and devices. The role requires coordinating with physicians, regulatory staff, and manufacturers to ensure timely submissions and compliance with FDA regulations. Responsibilities include preparing EA INDs, liaising with manufacturers, and guiding clinical teams through regulatory processes. The position emphasizes collaboration, accuracy, and patient-focused regulatory support in a

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