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.

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