Manage and execute regulatory tasks during product development, including strategy development, communication with regulatory authorities, submission of regulatory documents, tracking review progress, and resolving registration issues.
Coordinate with departments like CDE and NMPA, establishing and maintaining relationships with regulatory agencies and experts.
Assess new projects from a regulatory perspective, participate in developing registration strategies, and provide legal support to BD and clinical departments.
Keep up-to-date with global competition, regulatory environments, and guidelines, providing compliance guidance and risk management.

Master's degree or higher in Clinical Medicine or Pharmacy.
Over 5 years of experience in regulatory registration or related roles in multinational or major domestic pharmaceutical companies or clinical CROs, with a successful track record in drug IND or production applications.
Familiar with drug registration regulations and complete submission processes, capable of timely resolving development-related regulatory issues.
Extensive experience in liaising with relevant regulatory authorities.