CMC Regulatory Specialist, Post-Approval & Lifecycle

Medexus and Research Capital Corporation; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Medexus Pharmaceuticals Inc. seeks a Senior Specialist, Regulatory CMC to manage CMC change controls and regulatory work across Canada and the United States.

You will assess changes, determine reporting pathways, prepare post-approval submissions, and coordinate documentation with internal teams and external partners. You will lead multi‑project CMC changes, collaborate with QA, operations, labeling, and CDMOs, monitor FDA and Health Canada guidance, and ensure timely lifecycle management of the

Qualifications

• Bachelor’s degree in a life science or related field; chemistry, pharmaceutical sciences, biology or chemical engineering acceptable.
• 3+ years regulatory affairs in pharma/biologics with post-approval CMC experience.
• Experience preparing/coordinating post-approval CMC submissions for FDA and Health Canada.

Responsibilities

• Manage regulatory assessment and execution of CMC change controls for Canadian and U.S. products.
• Evaluate changes against dossiers; determine reporting category, data, approvals/notifications, and timing.
• Coordinate with QA and technical teams to resolve gaps and ensure compliant implementation.
• Lead multiple concurrent CMC changes and submission activities with timelines and supply impact.
• Prepare and coordinate post-approval CMC submissions and maintenance activities for Canada/U.S.
• Monitor FDA and Health Canada guidelines; adapt strategies and workflows accordingly.

Skills

Regulatory assessment

CMC change controls

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Education

Bachelor’s degree in life science or related field

Job description

Medexus Pharmaceuticals Inc. seeks a Senior Specialist, Regulatory CMC to manage CMC change controls and regulatory work across Canada and the United States.

You will assess changes, determine reporting pathways, prepare post-approval submissions, and coordinate documentation with internal teams and external partners. You will lead multi‑project CMC changes, collaborate with QA, operations, labeling, and CDMOs, monitor FDA and Health Canada guidance, and ensure timely lifecycle management of the