Introduction

Documentation Specialist - Regulatory Affairs (Contract Renewable) Remote - Ontario or Quebec

What are you going to do

Responsibilities

Organize, maintain, and manage electronic regulatory documents including applications, submissions, dossiers, and correspondence, on shared directories and other electronic platform,
Support regulatory project leaders to prepare administrative M1 documents for various typeds of Health Canada regulatory submissions (NDS, SNDS, Response to Clarifaxes etc.) efficiently and accurately in accordance with current Health Canada Guidelines and Corporate Guidance.
Overview and maintain regulatory shared mailbox by facilitating effective communication and coordinating correspondence to internal stakeholders.
Maintain accurate records of regulatory documents and submissions by upload regulatory dossiers and supportive information into corporate internal database and platform.
Act as a backup to the regulatory Regulatory Coordinator to provide operational support as needed.
Collaborate with regulatory affairs professionals, subject matter experts, and cross-functional local and global teams to gather necessary documentation and information for regulatory submissions and pharmacovigilance related safety reports.
Participate in any ad-hoc or special regulatory projects as needed.

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.
Experience with Veeva Vault and Insight for Viewing is a plus.
Strong attention to detail and organizational skills.
Excellent written and verbal communication skills.
Proficiency in document management software and tools.
Profiency in Microsoft Suite, Microsoft Team.
French/English bilingual is an asset.
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.

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.

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Anything Else?

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At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.

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Our ESG Commitment

Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.

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