Lead regulatory strategy and team management for pharmaceutical development, focusing on complex products. Drive successful product approvals through Health Canada while ensuring compliance and business growth.
Key Responsibilities
- Develop and execute regulatory strategies from product development through launch
- Lead and mentor regulatory affairs team
- Oversee submission preparation and filing with Health Canada
- Partner with R&D, Quality, and Business Development teams
- Manage relationships with licensing partners and regulatory agencies
- Review complex submissions and provide strategic guidance on regulatory feedback
- Ensure compliance with current regulatory requirements
- Support due diligence for new business opportunities
Required Qualifications
- Degree in Science or Life Sciences
- 10+ years of pharmaceutical industry experience
- 5+ years of experience with Canadian drug submissions
- Strong understanding of Health Canada regulations and ICH guidelines
- Experience with complex products preferred
Skills & Competencies
- Strategic thinking and project management
- Strong analytical and scientific writing abilities
- Excellence in team leadership and communication
- Ability to manage multiple priorities in a high-velocity organization
- Proven track record of successful regulatory submissions