Documentation Specialist

Responsibilities

1. Organize, maintain, and manage electronic regulatory documents including applications, submissions, dossiers, and correspondence on shared directories and other electronic platforms.
2. 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.
3. Overview and maintain regulatory shared mailbox by facilitating effective communication and coordinating correspondence to internal stakeholders.
4. Maintain accurate records of regulatory documents and submissions by uploading regulatory dossiers and supportive information into corporate internal database and platform.
5. Act as a backup to the Regulatory Coordinator to provide operational support as needed.
6. 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.
7. Participate in any ad-hoc or special regulatory projects as needed.

Essential skills and knowledge

Requirements

1. Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, chemistry).
2. Familiarity with Health Canada's regulatory requirements and guidelines.
3. Experience with Veeva Vault and Insight for Viewing is a plus.
4. Strong attention to detail and organizational skills.
5. Excellent written and verbal communication skills.
6. Proficiency in document management software and tools.
7. Proficiency in Microsoft Suite and Microsoft Teams.
8. French/English bilingual is an asset.
9. Previous experience in regulatory affairs or documentation management is a plus.