Regulatory Affairs Coordinator

Job summary

Organize and maintain electronic regulatory documents, prepare administrative Module 1 materials for Health Canada submissions, and manage regulatory correspondence and records in corporate systems. Coordinate with regulatory professionals and cross-functional teams to collect submission and pharmacovigilance documentation, while providing operational support and contributing to special projects.

Job details

Regulatory Affairs Coordinator (renewable contract) Remote – Ontario or Quebec Introduction We are currently hiring for a Regulatory Affairs Coordinator for our client based in Ontario or Quebec. The Regulatory Affairs Coordinator 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. Responsibilities Organize, maintain, and manage electronic regulatory documents including applications, submissions, dossiers, and correspondence on shared directories and other electronic platforms, Support regulatory project leaders to prepare administrative M1 documents for various types of Health Canada regulatory submissions (NDS, SNDS, Response to Clarifaxes etc.) efficiently and accurately in accordance with current Health Canada Guidelines and Corporate Guidance. Oversee and maintain the regulatory shared mailbox by facilitating effective communication and coordinating correspondence to internal stakeholders. Maintain accurate records of regulatory documents and submissions by uploading regulatory dossiers and supporting information into the corporate internal database and platform. Act as a backup 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. Requirements Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, chemistry). Fluency in French is an asset. Familiarity with Health Canada's regulatory requirements and guidelines. Experience with Veeva Vault and Insight for Viewing is a must. 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. Previous experience in regulatory affairs or documentation management is a plus. 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.

What you’ll do

Organize and maintain electronic regulatory documents, prepare administrative Module 1 materials for Health Canada submissions, and manage regulatory correspondence and records in corporate systems. Coordinate with regulatory professionals and cross-functional teams to collect submission and pharmacovigilance documentation, while providing operational support and contributing to special projects.

Requirements

A bachelor's degree in a relevant field is required, along with familiarity with Health Canada requirements and guidelines and experience with Veeva Vault and Insight for Viewing. Strong organizational, communication, and document-management skills are needed; French fluency and prior regulatory affairs or documentation experience are assets.

Listed skills

• Microsoft Teams · Preferred
• written communication · Preferred
• Organization · Preferred
• Attention to detail · Preferred
• Microsoft Office Suite · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory Documentation Management
• Health Canada Regulatory Requirements
• Regulatory Submission Preparation
• Document Management
• Veeva Vault
• Insight For Viewing
• Attention To Detail
• Organization
• Written Communication
• Verbal Communication
• Microsoft Office Suite
• Microsoft Teams
• Cross-Functional Collaboration
• Regulatory Correspondence

Job areas

• Healthcare
• Administrative
• Legal
• Science & Research

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