Regulatory Affairs and Quality Assurance Associate

Xediton Pharmaceuticals Inc.; Oakville; On-site; CAD 65,000 - 73,000; Full time

Benefits offered by this job

Accommodations available

Job summary

Xediton Pharmaceuticals Inc. in Oakville, Ontario, is seeking a Regulatory Affairs and Quality Assurance Associate to support Health Canada registrations for drugs, medical devices and natural health products.

You will prepare eCTD submissions, ensure GMP compliance, assist inspections, maintain SOPs, manage batch records, and coordinate with local and international sites to keep labeling and product monographs accurate.

Qualifications

• University science degree or equivalent in sciences with at least 3 years of Regulatory Affairs and QA experience.
• Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations.
• Extensive Knowledge of Canadian GMPs.
• Hands-on working knowledge of eCTD structure and requirements.
• Proficient with Microsoft Office (Word, Excel, Outlook).
• Excellent written and spoken communication; strong organizational skills.

Responsibilities

• Support 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

Regulatory affairs

Quality assurance

GMP knowledge

eCTD knowledge

Health Canada submissions

Education

University science degree or equivalent

Canadian regulatory accreditation recognition

Tools

eCTD software

Job 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.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 dynamic 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.