Chef de projets, Affaires réglementaires (CMC) / Project Manager, Regulatory Affairs (CMC)
Core
Managing Chemical Manufacturing Control (CMC) regulatory submissions for a pharmaceutical product portfolio to ensure compliance with Health Canada and global standards.
Role type
Project Manager, Regulatory Affairs (CMC)
Builds
Regulatory submissions for marketing applications and post-approval changes
Domain
Pharmaceutical / Biotechnology / Regulatory Affairs
Deliverable
Regulatory submissions
Required skills
Chemical Manufacturing Control (CMC) regulations, Health Canada submission processes, Project Management, Regulatory Compliance, Technical Writing, eCTD, Biologics knowledge
Preferred skills
Experience with biologics
Technologies
eCTD, Standard Office Software
Responsibilities
Coordinate planning and submission of CMC regulatory documents; Ensure submissions are complete, accurate, and prioritized to avoid supply impact; Manage follow-up with Health Canada until final decision; Act as primary liaison with Health Canada; Assess and respond to Health Canada information requests; File and maintain Clinical Trial Applications (CMC) in compliance with SOPs
Seniority
Mid-level, hands-on IC
