Linda Lemieux

Linda Lemieux is a Regulatory Affairs-CMC professional with over 27 years of experience in therapeutic development and commercialization. Linda has worked in small to large organizations on pre-clinical, clinical, commercial, and post-approval applications with the ability to develop regulatory strategy and submission plans in multiple markets for regulatory acceptance. Linda has expertise with various, diverse product types, including cell and gene therapies and biologics, with additional work in small molecules and medical devices. Linda’s current role is Senior Director/Senior Principal Scientist, Regulatory Affairs- CMC, Biologics and New Modalities at Merck & Co., Inc., based out of Boston, USA. Linda is active in several industry organizations including BIO, Biophorum, EFPIA, and CASSS WCBP Organizing Committee. Linda is a member of the ICH Q1/Q5C Expert Working Group, which is currently revising the international stability guidance. Linda has a Bachelor’s degree from Merrimack College in Biology and a Master’s Degree from Harvard University in Biological Sciences.