Take on the role of Regulatory Senior Manager in Montreal, QC, driving strategic plans for asset registration. Collaborate to ensure rapid patient access and compliance with health regulations.
Your core mission will involve leading the strategy for U.S. dossier development alongside marketing teams, developing risk mitigation strategies, and ensuring effective communication with health authorities. You will also direct preparations for health authority meetings, aiming to build strong relations while addressing regulatory challenges.
Key Responsibilities:
• Lead strategy for U.S. regulatory submissions
• Develop and execute contingency plans
• Address regulatory issues effectively
• Support health authority interactions
• Prepare responses to regulatory queries
Requirements:
• Scientific degree (Ph.D., M.D., PharmD, etc.)
• 2-8 years of regulatory experience
• Knowledge in neuroscience a plus
• Strong understanding of drug development regulations