Audrey Sue Lavoie
Director of Scientific, Business, and Regulatory Affairs
Audrey Lavoie MSc, Hon. BSc has over 15 years of experience in pharmaceutical research, animal research, statistical analysis and regulatory affairs. In her work with the Canadian Center for Veterinary Biologics of the Canadian Food Inspection Agency she performed pre and post-licensing regulatory oversight of veterinary vaccines, diagnostic kits, and antibody products, as well as evaluated licensing submissions for these products. At Abbott Point of Care, she authored and edited laboratory protocols and reports, performed statistical analyses as well as coordinated with regulatory affairs, quality control and laboratory personnel to complete verifications of Abbott Point of Care’s experimental diagnostic medical device. As an employee of Pfizer Vaccines Research, she worked in both the laboratory and animal care facilities. She performed and validated laboratory assays, authored laboratory protocols, analyzed data as well as developed data analysis systems, and coordinated laboratory animal studies. As part of her Masters of Science research project on the effects of GLP-1 on type 2 diabetes mellitus, she completed a systematic literature review including statistical meta-analysis.
She currently serves as the Director of Scientific, Business, and Regulatory Affairs with Paul Dick and Associates, and is involved with all aspects of product development, strategic business strategies and regulatory affairs for Canadian and international clients. She has extensive experience and expertise all along the product development spectrum. She is responsible for project management, proposal writing, management of the Pda team, podcasts, webinars, the preparation of market assessments, strategic business plans and product life plans, proof of concept studies, pivotal safety and efficacy trials, product development, regulatory strategies, pre-submission meetings with global regulatory agencies, grant applications, technical writing, and, the preparation and filing of regulatory dossiers.
She has also co-authored numerous reports and completed projects for a variety of clients, including major animal health companies, start-ups, investors, industry associations, government agencies, academic institutions and non-profit organizations. She has an in-depth understanding of international regulatory requirements for all types of animal health products, including veterinary drugs, veterinary biologics, feeds, veterinary health products and natural health products for human use. She is also fluent in French as well as English and works in both languages.
