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.

$name

Application process

First Contact

We carefully review your application and in the coming weeks, you will be notified for an interview session if you are selected. Only shortlisted candidates will be contacted within 7 days.

Scheduling an Interview

After being shortlisted, you will be contacted via email or telephone to arrange for a date on your availability for the qualification interview.

Phone/ Qualification Interview

During the interview, you will be assessed on your level of experience and skills, work history, availability, and the qualifications the company is seeking for the position.

Meeting in Real Life

After successfully making through the phone interview, a face to face interview will be scheduled between the candidate and recruiter. This session can be a more in-depth interview to review your communication and interpersonal skills.

Application for the Position

Submission of candidates resume for client’s approval and screening.