Marie DeGayner Kuker, RPh, RAC, FRAPS
Licensures and Certifications
Marie Kuker is a pharmaceutical regulatory affairs expert who has spent more than 35 years in increasing roles of responsibility in both large multi-national and small start-up pharmaceutical companies. Her expertise covers FDA drug applications in a wide variety of therapeutic areas, as well as having a key role in regulatory strategy for drug development and post marketing regulatory compliance issues.
She left her role as head of worldwide regulatory affairs for 3M Pharmaceuticals in 2007 to found Kuker Regulatory Consulting, LLC which specializes in pre- and post-market regulatory affairs and compliance for the biopharmaceutical industry. She is a registered pharmacist, Regulatory Affairs Certified, and an appointed Fellow of the Regulatory Affairs Professionals Society.
She is an Executive-in-Residence for the University of Minnesota Technology Commercialization Discovery Launchpad and an adjunct faculty member in the Center for Orphan Drug Research. She is also a faculty member of the Masters of Science program in Regulatory Affairs and Services at St. Cloud State University. An alumni of the University of Minnesota, she has served on the College of Pharmacy Board of Advisors and the Board of Directors of the Century Mortar Club and Alumni Association.
Awards & Recognition
Appointed Fellow, Regulatory Affairs Professionals Society