- Principal Consultant
- Pharma Regulatory Connection
Dr. Motola is a consultant to the Pharmaceutical Industry for Regulatory Affairs, Product Development, Product Compliance and product Due Diligence for both small molecules and biologics through her sole proprietorship, Pharma Regulatory Connection. She also acts as Vice President, RA of New Haven Pharmaceuticals, Inc. (since 2009), which she helped start up and participated in Series A and B financings. She has a wealth of Pharmaceutical Industry experience in the above areas, spanning over 30 years, including participation on the Management Teams of 3 pharmaceutical companies.
From 2008 to 2010, Dr. Motola served as a member of the Senior Leadership Team, as well as Senior Vice President, Regulatory Affairs, for Rib-X Pharmaceuticals, Inc., a development-stage anti-infective company. From 1998 until 2008 she was Vice President and Senior Vice President, Regulatory Affairs and Quality, at Alexion Pharmaceuticals Inc. As a member of the company’s Management Team, Dr. Motola built and managed the company’s global Regulatory Affairs organization and Quality Unit, while serving in a leadership role in the development, approval (US and EMEA), launch and lifecycle management of Alexion’s first product, Soliris® (eculizumab). Prior to Alexion she spent 7 years in Regulatory Affairs positions of increasing responsibility at Bayer Corporation, Pharmaceutical Division, where she led all US registration activities, encompassing early development, approval and lifecycle management of several investigational and marketed products, including Baycol® (cerivastatin sodium) and Adalat® CC (nifedipine). Prior to Bayer, Dr. Motola was a Regulatory Product Manager at Abbott Laboratories, where she managed, among other products, the Depakote® (divalproex sodium) product line, and E.R. Squibb and Sons, Inc., where, in addition to Regulatory Affairs, she began her industry career as a Research Investigator, Chemical Process Technology.
Dr. Motola has served on numerous discussion panels or advisory boards She received her Ph.D. and MS degrees in medicinal chemistry from the University of Rhode Island, College of Pharmacy, BA degree from Central Connecticut State University and is Regulatory Affairs Certified (RAC).