Regulatory Affairs Manager Health Canada (Montreal)

Regulatory Affairs Manager Health Canada (Montreal)

01 Nov
|
Bristol Myers Squibb
|
Montreal

01 Nov

Bristol Myers Squibb

Montreal

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.

📌 Regulatory Affairs Manager Health Canada (Montreal)
🏢 Bristol Myers Squibb
📍 Montreal

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