| Linda Lemieux is a Regulatory Affairs-CMC professional with over 25 years of experience in biotechnology and therapeutic development. Linda has worked in small to large organizations on pre-clinical, clinical, and commercial applications with the ability to develop regulatory strategy and submission plans in multiple markets for regulatory acceptance. Linda possesses an in-depth, working knowledge of the regulations and industry standards for various product types, including cell and gene therapies, biologics, and medical devices. Linda’s current role is Director/Principal Scientist, Regulatory Affairs- CMC, Biologics, Early Development at Merck & Co., Inc., Rahway, NJ, USA, where she leads the Biologic early development Regulatory CMC team. Previously, she worked at Cytiva/GE Healthcare, Baxter Healthcare, Ipsen, Advanced Cell Technology, as well as other small clinical-stage companies. She is also active in several industry organizations including BIO, Biophorum, and EFPIA. Linda has a Bachelor’s degree from Merrimack College in Biology and a Master’s Degree from Harvard University in Biological Sciences. |