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Documentation Specialist
3 months ago
Regulatory Affairs Documentation Specialist (renewable contract)
Remote – Ontario or Quebec
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.
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.
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.
- 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.
