Karen Lowitz

Karen Lowitz has extensive experience in regulatory affairs, currently serving as Associate Director of Regulatory Affairs at Biogen since April 2023. Previously, as Senior Regulatory Affairs Manager at Terumo Blood and Cell Technologies from March 2021 to April 2023, Karen managed regulatory support for various medical products and led a significant company-wide product change. Earlier roles include Regulatory Affairs Manager and Senior Regulatory Affairs Specialist, where responsibilities encompassed overseeing submissions for FDA approval and managing regulatory teams. Karen’s foundational career included positions at organizations such as Merck, Sandoz, and RMPDC - Denver Health, with a focus on regulatory submissions and cross-functional project coordination. Karen holds a Master’s degree in Business Administration from Monmouth University, a Master’s in Animal Science from Rutgers, and a degree in Marine Biology & Ecology from the Florida Institute of Technology.