min yang

• Managed product registration processes, ensuring full compliance with domestic and international regulatory standards. • Monitored and interpreted evolving regulations, providing timely updates and compliance guidance to cross-functional teams. • Prepared and coordinated official communications and submissions to regulatory authorities.

• Reviewed and verified clinical documentation within registration dossiers for imported pharmaceutical products. • Supported clinical site audits and ensured alignment with GCP and local regulatory requirements. • Organized and maintained investigator documentation, ensuring traceability and audit readiness. • Provided on-site operational and regulatory support to clinical investigators.

• Conducted analytical testing and quality assessments of pharmaceutical samples in compliance with GMP standards. • Prepared and reviewed technical reports, validation protocols, and laboratory documentation. • Contributed to the development and optimization of analytical methods for quality control. • Assisted in laboratory management, internal audits, and continuous improvement initiatives.