Remote Regulatory CMC Specialist—Lifecycle Submissions

Medexus Pharmaceuticals, Inc.; United States; À distance; USD 110 000 - 150 000; Plein temps

Résumé du poste

Medexus Pharmaceuticals Inc. is seeking a Senior Specialist, Regulatory CMC to oversee change controls and regulatory work for US and Canada. You will assess changes, determine reporting pathways, and coordinate post-approval submissions with internal teams and external partners.

You will manage multiple concurrent CMC changes, stay aligned with regulatory requirements, and support lifecycle management across a diverse portfolio. This role is remote within the United States.

Qualifications

• Bachelor’s degree in a life science or related field required.
• 3+ years of regulatory affairs experience in pharma/biologics.
• Hands-on experience assessing post-approval CMC changes.
• Experience preparing post-approval CMC submissions (FDA and Health Canada).
• Knowledge of Module 3 quality documentation, manufacturing processes, and quality systems.
• Ability to coordinate with internal teams and external partners.

Responsabilités

• Manage regulatory assessment and execution of CMC change controls for US and Canada.
• Evaluate changes against dossiers; determine reporting category and implementation timing.
• Independently assess routine CMC changes and escalate high-risk matters.
• Coordinate with QA and technical teams to resolve data gaps and ensure compliance.
• Manage multiple concurrent CMC changes and submission activities.

Connaissances

Regulatory affairs

CMC changes

FDA regulations

Health Canada

Post-approval submissions

Cross-functional collaboration

Formation

Bachelor’s degree in life sciences

Outils

eCTD submission tools

Description du poste

Medexus Pharmaceuticals Inc. is seeking a Senior Specialist, Regulatory CMC to oversee change controls and regulatory work for US and Canada. You will assess changes, determine reporting pathways, and coordinate post-approval submissions with internal teams and external partners.

You will manage multiple concurrent CMC changes, stay aligned with regulatory requirements, and support lifecycle management across a diverse portfolio. This role is remote within the United States.