Step into a pivotal role at Alexion as the Regulatory Affairs Manager in Canada. In this position, you will oversee critical regulatory submissions and collaborate with diverse teams, working in a flexible environment.
This managerial position entails engaging in regulatory strategy development for pharmaceuticals, managing submissions to Health Canada, and working alongside cross-functional teams. Your insights will facilitate compliance with regulations while ensuring timely completion of project deliverables, including the integration of AI tools.
Key Responsibilities:
• Lead regulatory activities for key product portfolios
• Prepare NDS/SNDS submissions and oversee communications
• Ensure timely stakeholder updates on regulatory matters




• Collaborate on clinical trial submissions and oversight
• Maintain SOPs and conduct regulatory policy reviews
Requirements:
• 5+ years of experience in pharmaceutical Regulatory Affairs
• Robust grasp of Canadian Food & Drug guidelines
• Excellent detail orientation and project management
• Familiar with AI applications in regulatory settings
• Preferred MSc. or PhD. in a relevant field
Drive regulatory success and transformative healthcare projects at Alexion in Canada.
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📌 Canada Regulatory Affairs Manager Role (Mississauga)
🏢 Alexion Pharmaceuticals,Inc.
📍 Mississauga