Related skills
regulatory submissions regulatory compliance health canada snds ectd📋 Description
- Regulatory submission support under Regulatory team guidance
- Coordinate preparation and maintenance of regulatory submissions
- Prepare and compile submissions for Health Canada (e.g., labeling changes)
- Assist with larger submissions (NDS, SNDS)
- Respond to Health Canada queries (Clarifax, NON, NOD)
- Collaborate with cross-functional teams to enable regulatory activities
🎯 Requirements
- B.Sc. in Biological or related sciences
- 1+ year Regulatory Affairs experience, preferably in Canada
- Knowledge of drug development process and Canadian drug laws
- Experience with eCTD submissions and Health Canada requirements
- Experience preparing and obtaining approval of therapeutic/labeling submissions
- Ability to work in a matrix environment and strong communication skills
🎁 Benefits
- Hybrid work option in Toronto
- 12-month contract with a major client
- Global CRO with focus on quality and development
- Supportive culture and professional growth
- Collaborative, cross-functional teams
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