The Role
- RA project management of new and developed products
- Provide regulatory strategic and operational input to local and global teams for development and marketed products throughout their lifecycle.
- Develop and execute filing strategies.
- Assessing and summarizing scientific and clinical information.
- Organize and coordinate meetings with Health Canada.
- Ensure the preparation of high-quality regulatory submissions to meet agreed upon timelines and in compliance with Health Canada Regulations.
- Ensure the ongoing compliance for marketed products, specifically through product monograph and label updates / revisions.
- Minimum of 5 years of experience in Regulatory Affairs.
- Demonstrated success in a regulatory environment (e.g., leading a major submission).
- Good knowledge of the current Health Canada regulations and PAAB guidelines.
- Strong strategic and operational thinking
- Strong stakeholder management skills.
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