Support Canadian pharmaceutical registrations and quality assurance at Xediton in Oakville, using eCTD submissions and Health Canada requirements.
This Regulatory Affairs and Quality Assurance Associate supports Drug, Medical Device, and Natural Health Product registrations. The work includes interpreting clinical and scientific information, maintaining GMP documentation, and responding to Health Canada requests. You will help secure market authorization and maintain compliance for existing products.
Key Responsibilities:
- Prepare and compile Drug submissions in eCTD format
- File Medical Device and Natural Health Product submissions
- Respond to Health Canada clarification and compliance requests
- Maintain SOPs, batch records, and manufacturing records
- Review labeling, monographs, and package inserts for compliance
Requirements:
- University Science Degree or recognized equivalent
- At least three years of Regulatory Affairs and QA experience
- Understanding of Canadian regulations, GMPs, and ICH requirements
- Hands-on eCTD knowledge, including Modules 1 to 5
- Solid communication, organization, and attention to detail
Apply regulatory submissions, GMP knowledge, and quality assurance expertise to support compliant products at Xediton Pharmaceuticals.