Regulatory Affairs Expert

Elevate your regulatory career with Freyr as a Regulatory Affairs Specialist based in Toronto, ON. Focus on managing pharmaceutical submissions to Health Canada with precision and expertise in a fully remote role.

Freyr, a leader in regulatory solutions for the life sciences sector, seeks a detail-oriented Regulatory Affairs Specialist to oversee critical submissions for pharmaceutical products in Canada. You will prepare, review, and coordinate regulatory dossiers while ensuring compliance with Health Canada’s evolving requirements. Collaborating with cross-functional teams and key stakeholders will be essential to achieving timely deliverables and maintaining high-quality submission standards.

Key Responsibilities:

• Prepare and submit regulatory dossiers to Health Canada

• Manage Module 1 documentation for submissions

• Coordinate responses to Health Canada queries

• Review and implement global CCDS updates in labeling

• Maintain submission trackers and regulatory compliance

Requirements:

• Bachelor's in Pharmacy, Life Sciences, Chemistry, or Biology

• 5+ years in Regulatory Affairs, specifically with Health Canada

• In-depth knowledge of Canadian regulations

• Strong project management and organizational skills

• Excellent written and verbal communication abilities

Contribute to Freyr's impactful regulatory projects while enhancing your expertise in compliance and submissions.
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