- About Us
J. Michael Nicholas, PhD, received his PhD in pharmacology from the University of Tennessee Center for Health Sciences. After postdoctoral work at the University of Mississippi in Jackson he joined Mylan Pharmaceuticals in Morgantown, WV as Director of Scientific Affairs. While at Mylan he later served as Director of Scientific and Regulatory Affairs and was involved with the development and approval of both generic and branded products. Following Mylan, he accepted a position with Marion Laboratories in Kansas City in the Regulatory Affairs department. Over the years Dr. Nicholas has been involved with all aspects of regulatory matters including product development and approval. While at Marion Laboratories, Marion Merrell Dow and Hoechst Marion Roussel, Dr. Nicholas served as the Director of Product Approval within the Regulatory Affairs Department and directed the submission of INDs, NDAs, and their subsequent approval. Prior to Teva, he was Vice President, US Regulatory Affairs and Compliance, Marketed Products for Aventis Pharmaceuticals and was responsible for regulatory matters for approved products. While at Teva, Dr. Nicholas had roles in US Regulatory Affairs, Pharmacovigilance and promotional material review, and was most recently Senior Vice President of Specialty Life Cycle Management, responsible for global product life cycle management for specialty products. Dr. Nicholas is currently the Founder and Principal at JMN Consulting, LLC.