Senior Clinical Regulatory Affairs Manager

Lead clinical regulatory strategy at Cencora, applying Health Canada expertise and client leadership across health product lifecycles. This is a full-time position.As Senior Manager, Regulatory Affairs, you will provide strategic consulting for drugs, biologics, devices, natural health products, and cosmetics. You will guide complex projects, submissions, client relationships, and regulatory authority interactions. Your work connects regulatory strategy with clinical, quality, medical, commercial, and development objectives.Key Responsibilities:
Lead regulatory strategy and consulting engagements for life sciences clientsDirect clinical and lifecycle submission preparation, review, and maintenanceDevelop labeling and support launch and promotional material reviewsLead agency meetings, briefings, and emerging issue recommendationsManage scope, timelines, budgets, quality, risks, and competing prioritiesRequirements:
Bachelor’s degree in a life-sciences disciplineFive to eight years of direct regulatory affairs experienceExperience developing pre-market and post-market submissionsKnowledge of Canadian requirements, Health Canada, and relevant ICH requirementsStrong strategic, analytical, communication, and relationship-building skillsBring clinical regulatory expertise, sound judgement, and client leadership to Cencora’s health product consulting practice.
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