Associate Regulatory Affairs Quality, Standards & Training Director (Global Patient Safety )

Role: Associate RA Quality, Standards & Training Director overseeing compliance for GPS and Regulatory Affairs, focusing on regulatory activities and inspection readiness. Responsibilities: monitor compliance metrics, ensure accuracy of safety and regulatory documentation, manage SOP updates, support audit/inspection preparation, track training compliance, and lead quality event investigations. Collaborates with Clinical Operations, QA, SMEs, and external partners to align regulatory standards and improve processes. Requirements: Bachelor's degree with 11+ years or Master's with 9+ years in regulatory affairs; 7-10 years pharma industry experience, preferably with audits/inspections. Skills: strong regulatory knowledge, project management, communication, and cross-functional collaboration. HighValue: extensive experience in regulatory compliance within biopharma, with emphasis on regulatory documentation, inspection readiness, and process improvement. Travel: approx. 10%. Location: not specified, likely hybrid based on role scope.