Introduction

Documentation Specialist – Regulatory Affairs (Contract Renewable)Remote - Toronto
Introduction
We are currently hiring a Documentation Specialist – Regulatory Affairs for our client based in Toronto. The Documentation Specialist in Regulatory Affairs is responsible for managing regulatory documentation related to healthcare products to ensure they meet the requirements and standards set by Health Canada. This role involves collaborating with regulatory affairs professionals and various stakeholders to maintain accurate and compliant documentation.

What are you going to do 

Responsibilities

  • Organize, maintain, and manage regulatory documents, including applications, submissions, dossiers, and correspondence.
  • Ensure that all documents are complete, accurate, and compliant with Health Canada's regulatory guidelines.
  • Assist in the preparation of regulatory submissions, such as New Drug Submissions (NDS), Medical Device License Applications (MDLAs), and other relevant documentation.
  • Review documents to ensure consistency, clarity, and adherence to regulatory requirements.
  • Conduct quality checks on documents to verify compliance with relevant standards and guidelines.
  • Identify and rectify discrepancies or errors in documentation.
  • Maintain version control of regulatory documents to ensure the availability of up-to-date information for the regulatory affairs team.
  • Collaborate with regulatory affairs professionals, subject matter experts, and cross-functional teams to gather necessary documentation and information for regulatory submissions.
  • Facilitate effective communication between internal and external stakeholders.
  • Stay current with Health Canada's regulatory requirements and guidelines.
  • Ensure that all documentation aligns with current regulatory standards.
  • Maintain accurate records of regulatory documents and submissions, including archival of historical data.

Essential skills and knowledge

Requirements

  • Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, chemistry).
  • Familiarity with Health Canada's regulatory requirements and guidelines.
  • Strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.
  • Proficiency in document management software and tools.
  • Previous experience in regulatory affairs or documentation management is a plus.

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.

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!