Senior Regulatory CMC Specialist - Remote Canada

Medexus Pharmaceuticals, Inc.; Canada; Remoto; CAD 100.000 - 140.000; Tempo pieno

Descrizione del lavoro

Medexus Pharmaceuticals Inc. is seeking a Senior Specialist, Regulatory CMC to manage change controls and regulatory work for Canada and the U.S. You will coordinate submissions, review technical content, and ensure timely regulatory compliance across a diverse product portfolio.

The role reports to the Senior Director, Regulatory Affairs & Pharmacovigilance and requires collaboration with QA, Technical Operations, and external partners to maintain lifecycle management and supply continuity.

Competenze

• Bachelor’s degree in a relevant life science or related scientific discipline.
• 3+ years of Regulatory Affairs experience in the pharmaceutical or biologics industry with post‑approval CMC experience.
• Experience preparing or coordinating post‑approval CMC submissions, with exposure to FDA- and Health Canada‑regulated products.
• Working knowledge of Module 3 quality documentation, manufacturing processes, specifications, analytical methods, stability, validation and pharmaceutical quality systems.

Mansioni

• Change Control Management and Regulatory Impact Assessment across Canadian and U.S. products.
• Post Approval CMC Submissions and Lifecycle Management coordination and review.
• Cross Functional Partner and Health Authority coordination to obtain required documentation and support supply continuity.
• Regulatory Strategy and Intelligence: monitor FDA and Health Canada CMC requirements and align plans.

Conoscenze

Regulatory affairs

Post-approval CMC

FDA/Health Canada

Change control

Documentation coordination

Formazione

Bachelor’s degree in life science

Descrizione del lavoro

Medexus Pharmaceuticals Inc. is seeking a Senior Specialist, Regulatory CMC to manage change controls and regulatory work for Canada and the U.S. You will coordinate submissions, review technical content, and ensure timely regulatory compliance across a diverse product portfolio.

The role reports to the Senior Director, Regulatory Affairs & Pharmacovigilance and requires collaboration with QA, Technical Operations, and external partners to maintain lifecycle management and supply continuity.