GRA CMC Manager

to lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management. In this role, you will shape global CMC regulatory strategy, ensure compliant execution of submissions and changes, and partner 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...