Regulatory Affairs and Quality Assurance Specialist

1 week ago


Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full time

Xediton Pharmaceuticals Inc is a privately-held pharmaceutical company committed to meeting the needs of patients, physicians, and partners.

We are seeking a highly motivated Regulatory Affairs and Quality Assurance Associate to support our team in Oakville, Ontario.

**Job Summary:**

The successful candidate will be responsible for supporting drug, medical device, and natural health product registrations with Health Canada. This includes preparing and filing submissions, interpreting clinical and scientific data, and ensuring compliance with regulatory requirements.

**Key Responsibilities:

  • Support the preparation and submission of eCTD dossiers to Health Canada
  • Prepare and file Medical Devices and Natural Health Products to Health Canada
  • Interpret clinical and scientific data to ensure compliance with regulatory requirements
  • Respond to requests from Health Canada and ensure timely compliance
  • Ensure all deadlines are met for annual drug notifications, Site License and DEL renewals
  • Participate in internal and regulatory audits, execute corrective actions as required
  • Maintain Standard Operating Procedures and review documentation for GMP purposes
  • Maintain batch records, master manufacturing and packaging records
  • Work with local and foreign site organizations on GMP matters
  • Ensure product labeling, package inserts, and product monograph are accurate and compliant

**Requirements:

  • University Science Degree or equivalent recognized by a Canadian University or Accreditation body
  • At least three years of experience in Regulatory Affairs and QA
  • Thorough understanding of Canadian Regulatory requirements, including Food & Drug Act and Regulations
  • Knowledge of ICH requirements and extensive knowledge of Canadian GMPs
  • Proficient computer skills, including Microsoft Office
  • Excellent communication and organizational skills

**Benefits:

The successful candidate can expect a competitive salary of $65,000 per annum, commensurate with experience. Xediton Pharmaceuticals Inc offers a dynamic work environment and opportunities for growth and development.



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