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 setting.

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 • Strong 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. #J-18808-Ljbffr

📌 Canada Regulatory Affairs Manager Role (Mississauga)
🏢 Alexion Pharmaceuticals,Inc.
📍 Mississauga