Regulatory Affairs and Services (M.S.)

Marie DeGayner Kuker

RPh, RAC, FRAPS, president, Kuker Regulatory Consulting, LLC.

Marie Kuker is the founder and president of Kuker Regulatory Consulting, a consulting firm specializing in biopharmaceutical regulatory affairs and compliance. She has more than 35 years of experience in the pharmaceutical industry with a particular emphasis in pre- and post-marketing drug development and regulatory affairs, compliance, regulatory strategy, drug-device combination products, and orphan drugs.

Prior to consulting, Marie was head of global regulatory affairs for 3M Pharmaceuticals and Drug Delivery Systems, a founding member of Orphan Medical, and a regulatory affairs manager at Upsher-Smith Laboratories.

Marie received her B.S. degree in Pharmacy from the University of Minnesota. She is Regulatory Affairs Certified and a Fellow of the Regulatory Affairs Professionals Society. She is Adjunct Assistant Professor in the Center for Orphan Drug Research of the University of Minnesota College of Pharmacy Department of Experimental and Clinical Pharmacology and Executive in Residence at the University of Minnesota Technology Commercialization Discovery Launchpad. She had been a faculty member of the Masters of Science program in Regulatory Affairs and Services at St. Cloud State University since 2010.


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