Regulatory Affairs Project Leader

Lead regulatory affairs projects for Sanofi in Toronto, coordinating Health Canada submissions and applying strategic, operational thinking across product lifecycles.As Regulatory Affairs Project Leader, you will support development and marketed products within Sanofi’s Canada Regulatory Affairs team. The work includes filing strategies, regulatory submissions, Health Canada engagement, and ongoing compliance. You will collaborate with local and global stakeholders while reviewing scientific and clinical information where applicable.Key Responsibilities:
Provide regulatory input throughout development and marketed product lifecyclesDevelop filing strategies and summarize scientific and clinical informationCoordinate meetings with Health Canada and internal stakeholdersPrepare submissions meeting timelines and Health Canada regulationsMaintain compliance through monograph, label, and promotional reviewsRequirements:
Bachelor of Science or health-related degree requiredTwo to three years of Regulatory Affairs experienceKnowledge of Health Canada regulations and PAAB guidelinesStakeholder management, strategic thinking, and analytical skillsEnglish proficiency;
French is an assetBringregulatory strategy, submission leadership, and stakeholder influence to Sanofi’s Toronto Regulatory Affairs team.
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