GRA CMC Specialist

Job description

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 CMC Scientists; may deputize for the CMC Team Lead. Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable: · Maintenance of the content of relevant parts of the regulatory dossiers. · Preparation, revision and review of Module 2.3, Module 3, required...