Regulatory Affairs Manager

Regulatory Affairs Manager (Contract – Renewable) Role Overview

We are seeking an experienced Regulatory Affairs Manager to support clinical-stage and lifecycle regulatory activities for innovative pharmaceutical products. This role will play a key leadership position in ensuring regulatory compliance, execution, and alignment across clinical development and post-approval activities in Canada.

The Regulatory Affairs Manager will act as a senior regulatory contributor and point of coordination, working closely with internal regulatory leadership, cross-functional partners, and Health Canada. This role requires a strong background in clinical regulatory submissions, the ability to operate hands‑on, and experience guiding regulatory work in a collaborative, matrixed environment.

• Lead and execute Canadian regulatory activities across clinical development and marketed products, ensuring compliance with Health Canada requirements
• Prepare, review, and submit clinical and lifecycle regulatory filings, including variations, labeling updates, and post‑approval submissions for innovative drugs
• Serve as a primary regulatory contact for Health Canada interactions, managing questions, clarifications, and follow‑up during review cycles
• Provide regulatory guidance and oversight to supporting regulatory resources to ensure high-quality, timely deliverables
• Collaborate with cross‑functional stakeholders including Clinical, Medical, Quality, CMC, and Global Regulatory teams to align regulatory strategy and execution
• Review promotional and non‑promotional materials to ensure regulatory compliance and consistency with approved labeling
• Maintain accurate regulatory documentation and records within internal systems in accordance with SOPs and regulatory standards
• Support continuous improvement of regulatory processes and ways of working

• Bachelor’s degree in Pharmacy or a health-related discipline
• 7–10 years of experience in Regulatory Affairs with a strong focus on clinical regulatory submissions for innovative pharmaceutical products
• Demonstrated experience working with Health Canada regulations and guidelines across clinical and lifecycle stages
• Prior experience providing leadership, guidance, or oversight to regulatory team members or project resources
• Strong understanding of eCTD publishing requirements and regulatory documentation standards
• Excellent communication, judgment, and decision‑making skills
• Ability to manage multiple priorities in a fast‑paced, regulated environment
• Proficiency with Microsoft Office and Adobe Acrobat
• Bilingual French and English (written and spoken) considered an asset

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