Introduction

Regulatory Affairs Manager (Contract - Renewable)

Remote - Ontario

What are you going to do

Key Responsibilities

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

Essential skills and knowledge

Requirements

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

What we offer

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

Closing: May 19, 2026

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Do you have any questions about this vacancy?

Vacancy reference: CR-279232

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Corporate recruiter

Alyssa DeRosario

+1 403 539 5009

Contact

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