Quality Assurance and Regulatory Affairs Associate
1 week ago
Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE
The Regulatory Affairs Associate will support Drug, Medical Devices and Natural Health Product registrations with Health Canada.
Support the preparation and filing of Medical Devices and Natural Health Products to Health Canada
Ability to Interpret clinical, scientific data and information
Respond to requests from Health Canada - clarification for new submissions and compliance for existing products.
Ensure all HC requirements and deadlines are met as it relates to annual drug notifications, Site License and DEL renewals.
Support in preparing for regulatory inspections, participate in internal and regulatory audits as required and execute the necessary corrective actions
Maintain all documents - Batch Records, Master Manufacturing and Packaging Records
Work with local and foreign site organizations on GMP matters to resolve issues as needed
Assist in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations
University Science Degree or degree recognized as equivalent by a Canadian University or Accreditation body in Sciences with at least three years of previous Regulatory Affairs and QA experience.
Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
· Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
· The successful Candidate will possess excellent attention to detail and have the ability to manage time and complex RA and QA projects.
· To apply, please email your application and resume through our website
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Oakville, ON, Canada Xediton Pharmaceuticals Inc Full timeXediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE The Regulatory Affairs Associate will support Drug, Medical Devices and Natural Health Product registrations with Health Canada. Support the preparation and filing of Medical...
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Oakville, ON, Canada Xediton Pharmaceuticals Inc Full time €65,000Company Description: Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate will support...
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Oakville, ON, Canada Xediton Pharmaceuticals Inc Full timeCompany Description: Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate will support...
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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, Canada Xediton Pharmaceuticals Inc Full timeCompany Description:Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit www.xediton.comREGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate...
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Oakville, Canada Xediton Pharmaceuticals Inc Full timeCompany Description:Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit www.xediton.comREGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate...
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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 timeXediton 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...
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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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