Introduction

Managed Services Specialist, Regulatory Affairs (renewable contract)

Remote - Ontario or Quebec

What are you going to do 

Responsibilities

  • File regulatory submissions (from the company's portfolios) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels.
  • Update required the company's internal systems and databases with regulatory affairs information, as per their SOP's such as Vault RIM.
  • Communicate and work with the company's local (eg, Canada brand team) and global stakeholders, according to their SOPs.
  • Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada.
  • Interact directly with Health Canada, and to address questions on filed submissions to ensure approval.
  • Create detailed Yearly Biologic Product Reports (YBPR) by gathering data from the CPID, following regulatory guidelines and coordinating communication with key stakeholders.
  • Oversee and coordinate the submission of Public Release of Clinical Information (PRCI), ensuring clear communication with internal teams and Health Canada.

Essential skills and knowledge

  • Requirements
  • Bachelor degree in pharmacy or any health-related field.
  • Minimum of 1-3 years previous experience in the preparation of regulatory submissions specific to innovative drugs.
  • English (written and spoken), French is an asset.
  • Good understanding of the current Health Canada regulations and guidelines (CMC, clinical, and labeling).
  • Good team work and ability to work independently.
  • Computer knowledge of Microsoft Office Suite; Adobe Acrobat.
  • Organised, attention to detail and deadline driven.

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: 18 August 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

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!