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

Required Qualifications

  • 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: 24 May 2026

Apply Now

Are you the perfect match for this vacancy? Apply in 5 minutes and let's get in touch!

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Process of your application

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Application process & contact

We will now begin examining your application: We will take a close look at your application documents and ask you for additional information if necessary. If your qualifications match our requirements, we will invite you to meet us for the first time.

Project discussion with our customer

If the introductory meeting goes well for you and us, we will arrange a meeting with the customer who has the perfect project for you. This gives you the opportunity to find out more about the customer and the project.

The decision

If you enjoyed the project discussion and the customer is also convinced of your expertise, we will ask you the final and decisive question: Do you want to get started at Brunel?

Introductory conversation with Brunel

In an introductory meeting, we would like to find out more about your interests, ambitions and professional developments. At the same time, we report on working at Brunel and provide information about all career opportunities and prospects.

Welcome to Brunel

Now great times are beginning! With Brunel you have countless opportunities to help shape technological progress. You decide how your career path goes. We support you in every phase of your career. You always have security behind you: Brunel!