Regulatory Scientist in Madison, WI for University of Wisconsin Madison
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Regulatory Scientist
Job Summary: The successful applicant will be part of the University of Wisconsin-Madison's Program for Advance Cell Therapy (PACT) multidisciplinary team led by Associate Dean Jacques Galipeau and focused on deployment of cell and gene therapy first-in-human and early phase clinical trials in partnership with UW Health clinical translational research professionals. The candidate will lead and manage FDA CBER IND & IDE application preparation and submission; IND & IDE maintenance including reports and amendments using Florence Healthcare eBinders; preparation for internal and external compliance reviews of FDA related regulatory documents; and assisting IND/IDE Study UW clinical Principal Investigators with protocol developmen


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