The Centre for Probe Development and Commercialization (CPDC) is a global leader in the discovery, development and distribution of next generation radiopharmaceuticals. Our products are used daily for the detection and treatment of human diseases such as cancer. CPDC offers career growth and development in a highly entrepreneurial environment. CPDC offers medical and dental benefits, sick days and more.
- Competitive compensation including group benefits
- Opportunity for long-term growth
- Professional, collaborative environment
- Innovative and interesting work that makes a positive impact on patients and Canadian healthcare
The Regulatory Affairs Associate (permanent) - will be responsible for activities, which include but are not limited to:
- Prepare, publish and submit regulatory filings for investigational drugs, marketed drugs, (Drug) Master Files, and establishment licensing (Health Canada and FDA). Submission activities include administrative, clinical and CMC components, and publishing.
- Prepare regulatory documents for pre-submission meetings (e.g., pre-CTA meetings)
- Perform pharmacovigilance activities (ADR reports, literature/database searches & Annual Summary Reports)
- Contribute to the development/improvement of internal regulatory procedures
- Ensure that all work is performed in compliance with SOPs, GxP and regulatory requirements, and maintain current knowledge of these requirements
- Prepare, review and update regulatory (e.g., Investigators' Brochures, Product Monographs, product labels) and quality documents
- Assess change controls and, where required, contribute to the planning/implementation of changes
- Maintain regulatory documentation, filing systems, spreadsheets, databases, etc.
- Liaise with Quality Assurance, product development, production, analytical and other groups to obtain information and ensure successful completion of project deliverables
- Maintain up-to-date regulatory intelligence
- Provide clear, accurate, and timely feedback to the Regulatory Affairs Manager about project status
- Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality
Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals
- Any other assigned duties to support the Regulatory and Clinical department, and the CPDC's overall goals
- B.Sc. in a scientific field, preferably biological sciences or chemistry; an M.Sc. in these fields is an asset
- Completion of a post-graduate Regulatory Affairs certification course is preferred
- Minimum 4 years' working in Canadian Regulatory Affairs, including experience with commercial (Division 8) and investigational product submissions
- Experience with CMC, clinical and operational aspects of Regulatory Affairs
- Background with prescription pharmaceutical products; specific experience with radiopharmaceuticals and/or sterile products is an asset
- Must be able to work independently and take initiative, and possess excellent organizational skills
- Must have excellent attention to detail and the ability to quickly and critically analyze scientific data
- Strong proficiency in the English language with excellent verbal and written communication skills
- Proficient with MS Office (Word, Excel, Powerpoint, etc.) and Adobe software; experience with eCTD publishing is an asset
If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at email@example.com
We thank all those who apply but only candidates selected for interviews will be contacted.