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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
Fred Hutchinson Cancer Center
Multiple Locations, Washington
University of North Carolina Wilmington
Wilmington, North Carolina
Baylor Scott & White Health
Round Rock, Texas
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Regulatory Affairs Coordinator
Objective The Regulatory Affairs Coordinator will provide various regulatory and administrative support for the clinical research programs. The position will assist with regulatory document preparation, editing of regulatory and clinical documents and provide general administrative support to the Clinical and Manufacturing teams. Regulatory Support Duties Assists in preparation and review of Clinical Trial Protocols, Study Reports, Investigator’s Brochures, etc. Assists in preparation of non-clinical (M 2.4, 2.6), (M 4) and clinical (M 2.5, 2.7) parts of the CTD dossier for INDs in the USA with subsequent submission of the regulatory documents to the eCTD publisher. Assists in the preparation of clinical
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