Regulatory Affairs and Quality Assurance Specialist
1 week ago
Xediton Pharmaceuticals Inc is a dynamic privately-held pharmaceutical company headquartered in Oakville, Ontario. We are committed to meeting the needs of patients, physicians, and partners by providing high-quality products and services.
Job SummaryWe are seeking an experienced Regulatory Affairs and Quality Assurance Associate to join our team. As a key member of our regulatory team, you will play a crucial role in supporting drug, medical devices, and natural health product registrations with Health Canada. Your expertise in preparing and filing submissions, interpreting clinical and scientific data, and ensuring compliance with regulations will be invaluable to our organization.
Key Responsibilities:- Support the preparation and submission of drugs, medical devices, and natural health products to Health Canada in the eCTD format.
- Prepare and file Medical Devices and Natural Health Products to Health Canada.
- Interpret clinical and scientific data to ensure accurate submissions.
- Respond to requests from Health Canada regarding new submissions and compliance for existing products.
- Maintain Standard Operating Procedures and review documentation for GMP purposes.
- Work with local and foreign site organizations to resolve GMP issues.
- Ensure product labeling, package inserts, and product monograph accuracy and compliance.
- Assist in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations.
- Bachelor's degree in Science 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 interpretation of the Food & Drug Act and Regulations.
- Extensive knowledge of Canadian GMPs.
- Excellent communication skills (written and oral).
- Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines.
Estimated Salary Range: $65,000 per annum
If you are a motivated and dedicated individual with excellent analytical skills, we encourage you to apply for this exciting opportunity. Please submit your application and resume through our website at www.xediton.com/contact-us/careers/. While we appreciate the interest of all applicants, only candidates selected for an interview will be contacted.
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Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full timeXediton 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...
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Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full timeAbout Xediton Pharmaceuticals IncXediton Pharmaceuticals Inc is a privately-held pharmaceutical company dedicated to meeting the needs of patients, physicians, and partners.We are located in Oakville, Ontario, where we strive to make a positive impact on people's lives through innovative solutions.Job Title: Regulatory Affairs and Quality Assurance...
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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...
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