Kevin P. Malobisky, Ph.D., M.S., RAC

SVP Global Regulatory Affairs and Quality & Compliance

Kevin joined Achillion in 2018 and brings nearly 30 years of pharmaceutical and biotechnology experience in building and leading high performing, global teams in Regulatory Affairs, Quality & Compliance, Pharmacovigilance, and Clinical Development. This experience includes the successful submission and filing of multiple Investigational New Drug Applications (IND), Orphan Drug Applications, New Drug Applications (NDA) and Marketing Authorization Applications (MAA) in the U.S. and E.U., respectively, as well as leading numerous regulatory meetings and interactions with global health authorities across many different therapeutic orphan and non-orphan indications.

Kevin joined Achillion from Karyopharm Therapeutics where he was the Senior Vice President for Global Regulatory Affairs, Pharmacovigilance, and Quality and was responsible for leading the successful filing of their first NDA for a new molecular entity to treat penta-refractory multiple myeloma under both Fast Track and Priority Review designation. Prior to Karyopharm, Kevin served as the Global Head of Regulatory and Quality at Zafgen, Inc where he built the teams that led the Phase 3 development of an innovative treatment for Prader-Willi Syndrome, a rare genetic metabolic disease. Kevin also spent 14 years at Sanofi where he held leadership roles of increasing responsibility for the regulatory development of multiple Phase 1-3 programs in fibrosis, wound repair, liver and metabolic diseases including non-alcoholic steatohepatitis, diabetes and obesity. He was also responsible for leading the commercial regulatory affiliate organizations in the U.S. and Canada, overseeing advertising, promotion, and compliance activities. Kevin started his career at Hoffmann-LaRoche Pharmaceuticals in virology research, in vitro diagnostic device development, and clinical/regulatory affairs.

Kevin earned his Bachelor of Science degree in Microbiology with a minor in Marine Sciences from the Pennsylvania State University, a Master of Science degree in Quality Assurance and Regulatory Affairs from the Temple University School of Pharmacy, and a Doctor of Philosophy degree in Organization Management from the Capella University School of Business and Technology, graduating with distinction. Kevin is also certified in regulatory affairs (US RAC) from the Regulatory Affairs Professional Society.