Regulatory Affairs Project Leader Toronto

Lead regulatory affairs projects in Toronto with Sanofi, applying Health Canada knowledge and strategic thinking across product lifecycles. Occasional travel is required.As a Regulatory Affairs Project Leader, you will support development and marketed products for Sanofi’s General Medicine, Specialty Care, and Vaccine portfolio. The Canada Regulatory Affairs team prepares submissions, coordinates with Health Canada, and maintains compliance. Your work will combine filing strategy, regulatory submissions, stakeholder influence, and product labeling.Key Responsibilities:
Provide strategic and operational regulatory input throughout product lifecyclesDevelop filing strategies and summarize scientific and clinical informationCoordinate Health Canada meetings and regulatory authority interactionsEnsure quality submissions meet timelines and Health Canada regulationsMaintain compliance through labeling and promotional material reviewsRequirements:
BSc or degree in a health-related fieldMinimum two to three years of Regulatory Affairs experienceSuccess in a regulatory environment, including major submissionsKnowledge of Health Canada regulations and PAAB guidelinesEnglish proficiency;
French is an assetApplyregulatory strategy, Health Canada expertise, and stakeholder management to Sanofi products in Toronto.
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