GRA CMC Manager

Responsible for leading strategic and operational CMC regulatory activities across product development, clinical submissions, registrations and lifecycle management. The role shapes global CMC regulatory strategy, ensures compliant execution of submissions and changes, and partners with technical and regulatory teams worldwide.

Key Responsibilities

• Drive global CMC strategies for clinical trial applications, new product licenses and post‑approval changes.
• Assess CMC, facility/equipment, and plasma‑related changes and manage regulatory submissions in coordination with regional teams.
• Serve as primary regulatory liaison with technical experts; support GMP inspections and inspection readiness.
• Interpret regulatory guidelines and requirements; prepare impact assessments and contribute to process improvements.
• Provide technical guidance to CMC scientists; may deputize for the CMC Team Lead.
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