Regulatory Affairs Specialist with Quality Assurance Focus

1 week ago

Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full time $65,000

**About Xediton Pharmaceuticals Inc.**

Xediton is a privately-held pharmaceutical company dedicated to addressing the needs of patients, physicians, and partners.

We are committed to meeting the evolving requirements of the industry while fostering a culture of innovation and excellence.

**Job Overview:**

The Regulatory Affairs Associate will support the preparation, compilation, and submission of Drug, Medical Devices, and Natural Health Product registrations with Health Canada.

This role requires strong analytical skills, attention to detail, and excellent communication abilities to ensure seamless interactions with regulatory bodies.

**Key Responsibilities:**

  • Support the preparation and filing of Drugs in the eCTD format to Health Canada
  • Prepare and file Medical Devices and Natural Health Products to Health Canada
  • Interpret clinical and scientific data to inform regulatory submissions
  • Respond to requests from Health Canada regarding new submissions and compliance for existing products
  • Ensure adherence to annual drug notifications, Site License, and DEL renewals as required by Health Canada
  • Participate in internal and regulatory audits, executing corrective actions as needed
  • Maintain Standard Operating Procedures and review documentation for GMP purposes
  • Manage batch records, Master Manufacturing, and Packaging Records
  • Collaborate with local and foreign site organizations on GMP matters to resolve issues
  • Verify product labeling, package inserts, and product monographs for accuracy and compliance
  • Contribute to the development of procedures and processes ensuring compliance with the Food and Drug Act and Regulations

**Requirements and Qualifications:**

The ideal candidate possesses a University Science Degree or equivalent, with at least three years of experience in Regulatory Affairs and QA.

Candidates should demonstrate:

  • Thorough understanding of Canadian Regulatory requirements and ICH guidelines
  • Extensive knowledge of Canadian GMPs and eCTD structure
  • Excellent document management and organizational skills
  • Proficiency in Microsoft Office (Word, Excel, Outlook)
  • Strong communication and problem-solving abilities

**Estimated Salary: $65,000 per annum**, commensurate with experience.

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