Regulatory Affairs and Quality Assurance Expert
1 week ago
Xediton 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 AssociateThe Regulatory Affairs Associate will play a critical role in supporting Drug, Medical Devices, and Natural Health Product registrations with Health Canada.
Responsibilities include:
- eCTD Submissions: Prepare, compile, notify, amend, and submit Drugs in the eCTD format to Health Canada for market authorization.
- Device and Product Filings: Prepare and file Medical Devices and Natural Health Products with Health Canada.
- Data Interpretation: Interpret clinical and scientific data to inform regulatory decisions.
- Health Canada Compliance: Respond to requests for clarification on new submissions and ensure compliance with existing products.
- Deadline Management: Ensure all Health Canada requirements and deadlines are met for annual drug notifications, Site License, and DEL renewals.
- Regulatory Inspections: Participate in internal and regulatory audits, prepare for inspections, and execute corrective actions as needed.
- GMP Documentation: Maintain Standard Operating Procedures and review documentation for GMP purposes.
- Record Maintenance: Maintain batch records, master manufacturing and packaging records, and work with local and foreign site organizations on GMP matters.
- Product Labeling: Ensure product labeling, package inserts, and product monographs are accurate and compliant.
- Finished Product Release: Oversee the release of finished products.
To succeed in this role, you will need:
- Critical Thinking: Apply good judgment and analytical skills to resolve complex issues.
- Communication Skills: Effectively communicate with cross-functional teams and external stakeholders.
- Organizational Skills: Prioritize tasks, manage multiple projects, and meet deadlines.
- Technical Skills: Proficiency in Microsoft Office (Word, Excel, Outlook) and working knowledge of eCTD structure and requirements.
This is an excellent opportunity for a highly motivated individual who is passionate about regulatory affairs and quality assurance. If you are a team player with a strong work ethic and a commitment to excellence, we encourage you to apply.
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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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