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Fred Hutchinson Cancer Center
Multiple Locations, Washington
University of North Carolina Wilmington
Wilmington, North Carolina
The Henry M. Jackson Foundation for the Advancement of Military Medicine
Bethesda, Maryland
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Regulatory Affairs Professional
Advise on responses to technical questions raised by US FDA and Health Canada, or other regulatory authorities. Responsible for submission of documents to US FDA and Health Canada, or other regulatory authorities, such as a 483 inspection response. Evaluate classification of drug recalls, implementation of recalls. Evaluate, advise and prepare Field Alert Reports. Evaluate, advise and prepare Recall Reports. Monitor resolution of situations involving compliance issues. Participates in the enforcement of compliance of establishments and products, with current good manufacturing practices (CGMP) and other adulteration provisions of the Title 21 of the Code of Federal Regulations and Federal Food, Drug and Cosmetic Act.
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