Documentation Specialist - Regulatory Affairs

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.