Senior Regulatory Affairs Manager Canada

Lead regulatory strategy across Canada using Health Canada expertise and client leadership for complex health product consulting engagements. Remote work options are available.This Senior Manager, Regulatory Affairs position supports life sciences clients across the health product lifecycle. You will guide pharmaceuticals, biologics, medical devices, natural health products, and cosmetics through regulatory requirements. The work spans submissions, agency interactions, product launches, and commercialization.Key Responsibilities:
Lead regulatory strategy and consulting engagementsDirect submissions, amendments, responses, and post-approval activitiesGuide Health Canada and U.S. FDA interactionsManage concurrent projects, budgets, timelines, and quality standardsBuild trusted client relationships and support business developmentRequirements:
Bachelor's degree in a life sciences disciplineFive to eight years of Regulatory Affairs experienceExperience developing pre-market and lifecycle submissionsKnowledge of Canadian requirements, Health Canada, and ICH guidelinesStrong strategic, analytical, communication, and decision-making skillsApply regulatory expertise, client leadership, and strategic judgement to advance health products through complex Canadian regulatory pathways.
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