Marie-Eve Charrois, MA
Vice President, Regulatory Affairs and Pharmacovigilance
Marie-Eve is in charge of developing the regulatory dossier and obtaining the required authorization to achieve IMV’s clinical programs. She also oversees the pharmacovigilance and activities related to the clinical safety of the investigational products used in IMV sponsored clinical trials. She brings 25 years of experience in research and in the biopharmaceutical industry. She developed an expertise in supporting the clinical development and ensuring the regulatory compliance of several types of innovative biologics and licensed vaccines. During her 18-year experience at Medicago (a biotech company developing Virus-Like Particle vaccine), she has served in many roles of increasing responsibility in Research, Quality, and Regulatory Affairs, and the five last years as Director of Regulatory Affairs. As Site Conformance Manager at GSK Vaccine (Quebec City facility), she has played an active role in the development of regulatory strategies for the implementation of changes to the licensed manufacturing process and obtaining the necessary approval to allow the Seasonal Influenza vaccine to be released and delivered in time. She was also in charge of the preparation for GMP inspections by the GSK Global Quality organization and the Regulatory Agencies. Over her career, she was involved in the preparation of the regulatory dossier to support several Phase 1, 2, and 3 clinical trials conducted in Canada, USA, Europe, South Africa, and Australia. She has actively participated in formal and technical meetings with regulatory authorities (FDA, Health Canada BRDD, and EMEA) in the context of the vaccine development, and also in the context of regulatory interactions associated with the maintenance of licensed vaccines. Marie-Eve also successfully contributed to the development of the CMC/Quality sections of submission packages for license applications (BLA in US and NDS in Canada) and post-approval changes. More recently, she was selected in the first cohort of the Excellence in Canadian Board Governance (ECBG) Program from the McGill University Executive Institute and completed the program developed in collaboration with Executive Women in Bio (WIB - Greater Montreal). Marie-Eve also owns a Master of Arts from Laval University in Quebec.