Advance Health Canada submissions at Xediton Pharmaceuticals in Oakville through eCTD dossier preparation and regulatory compliance support.

As a Regulatory Affairs and Quality Assurance Associate, you will support registrations for Drugs, Medical Devices, and Natural Health Products. You will compile eCTD dossiers, interpret clinical and scientific data, and address Health Canada questions. The position also supports annual notifications, license renewals, inspections, and audits.

Key Responsibilities:

- Compile eCTD dossiers across Modules 1 to 5
- Prepare notifications, amendments, and submissions for Health Canada
- Meet annual notification, Site License, and DEL deadlines
- Support regulatory inspections, audits, and corrective actions




- Develop compliance procedures under Food and Drug Regulations

Requirements:

- Science degree recognized by a Canadian university or accrediting body
- Three or more years of Regulatory Affairs and QA experience
- Thorough knowledge of Canadian regulatory requirements
- Extensive Canadian GMP knowledge and working ICH knowledge
- Ability to manage complex projects and multiple deadlines

Bring eCTD dossier experience, Health Canada knowledge, and regulatory judgment to Xediton's Oakville pharmaceutical operations.

📌 Health Canada Regulatory Submissions Associate (Oakville)
🏢 XEDITON PHARMACEUTICALS
📍 Oakville