Linda Lemieux

Linda Lemieux is a Regulatory Affairs-CMC professional with almost 30 years of experience in therapeutic product development and commercialization. Linda has worked in small to large organizations on pre-clinical, clinical, and commercial applications with the ability to develop regulatory strategies and submission plans in multiple markets. Linda has experience with various, diverse product types, specializing in biologics and cell and gene therapies. Her current role is Senior Director/Senior Principal Scientist, Regulatory Affairs- CMC, Biologics and New Modalities at Merck & Co., Inc., Rahway, NJ, USA (primarily based in Boston, MA). Linda is a member of the ICH Q1/Q5C Stability guideline revision Expert Working Group representing BIO. Linda is active in several industry organizations including BIO and the CASSS WCBP Scientific Organizing Committee. She has a Bachelor’s degree from Merrimack College in Biology and a Master’s degree from Harvard University in Biological Sciences.