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.com
REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key Responsibilities The Regulatory Affairs Associate will support Drug, Medical Devices and Natural Health Product registrations with Health Canada.
Specific responsibilities include: Support the preparation, compilation, notification, amending and submissions of Drugs in the eCTD format to Health Canada to obtain market authorization
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 Standard Operating Procedures; Review of documentation for GMP purposes
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
Ensure that product labelling, package inserts and product monograph are accurate and compliant
Finished Product Release
Assist in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations
Skills & Qualification The successful candidate is a highly motivated, enthusiastic and energetic team player who is resourceful and dedicated and has competencies in adapting to changing environments.
Educational Qualification University Science Degree or degree recognized as equivalent by a Canadian University or Accreditation body in Sciences with at least 3 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.
Extensive Knowledge of Canadian GMPs
Hands-on working knowledge of eCTD structure and requirements
Proven track record of compiling eCTD dossiers- Modules 1 to 5
Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
Excellent communication skills(written and oral)
Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
The successful Candidate will possess excellent attention to detail and have the ability to manage time and complex RA and QA projects.
Self-starter who is able to work independently with minimal supervision
Salary: $65,000 - $72,500 per annum
Xediton Pharmaceuticals Inc. is committed to fostering an inclusive and accessible workplace. Accommodations are available throughout the recruitment and selection process upon request. We review all applications through a fair, human-led process and do not use artificial intelligence (AI) to screen or make hiring decisions on resumes.