31 Oct
|
Bristol Myers Squibb
|
Quebec City
31 Oct
Bristol Myers Squibb
Quebec City
Lead Canadian regulatory strategy at Bristol Myers Squibb in Montreal, coordinating Health Canada submissions and global product teams. English and French required.
This Regulatory Affairs Manager represents Canada for assigned products on Global Regulatory Teams. The position develops regulatory strategies, manages reviews, and supports timely approvals. It requires knowledge of drug development, Health Canada requirements, and scientific principles across chemistry, toxicology, pharmacology, and statistics.
Key Responsibilities: Represent Canada on Global Regulatory Teams for assigned products
Develop strategies with local and global cross-functional teams
Identify regulatory risks and communicate mitigation plans
Manage Health Canada filings, interactions, and negotiations
Review clinical,
safety, nonclinical, manufacturing, and promotional materials
Requirements: Bachelor’s degree in science; master’s degree is an asset
Minimum seven years of regulatory or pharmaceutical industry experience
Knowledge of Health Canada regulations, policies, and guidance
English and French written and oral proficiency
Robust computer, scientific, communication, and business skills
Apply regulatory strategy, Health Canada expertise, and bilingual communication to support assigned products at Bristol Myers Squibb.
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📌 Regulatory Affairs Manager Health Canada (Quebec City)
🏢 Bristol Myers Squibb
📍 Quebec City