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Documentation Specialist - Regulatory Affairs
Canada, Ontario, North York
Introduction
Documentation Specialist – Regulatory Affairs (Contract Renewable)Remote - Toronto
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.
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.
What are you going to do
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.
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.
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication skills.
- Proficiency in document management software and tools.
- Previous experience in regulatory affairs or documentation management is a plus.
What we offer
What We Offer
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