regulatory affairs director.

• • Responsible for China domestic drug registration and filing, formulating registration strategy, evaluating registration risks, establishing registration pathways, and successfully completing various registration tasks. Drafting and editing IND, NDA, and other types of filing documents, as well as tracking the progress of project reviews, approvals, and inspections.
  • Develop and maintain the effective relationships with the China commercial organization and other support functions. Provide regulatory leadership and guidance/advice on local country regulatory environments. Provide assessment of the impact of new and changing regulations/requirements in China.
  • Establish standard registration processes and operating procedures in accordance with regulatory authorities' laws, regulations, and policy requirements. Proven expertise in crafting and executing registration strategies, complemented by a comprehensive understanding of the entire IND and NDA lifecycle；hands-on experience with IND and NDA submissions； demonstrated ability to navigate complex regulatory landscapes and effectively communicate with CDE.
  • Track the entire product development process, provide guidance on the direction of R&D from the perspective of registration regulations and guidelines, to ensure the focus and depth of R&D meet the official review requirements.
  • Lead registration related discussion with CDE. Maintain good relationship with NMPA/CDE and other appropriate regulatory agencies.

skills and experience required.

• Pharmaceutical, medical, or other relevant majors, with a master's degree or above.
• 10+  years of industry experience in MNC companies in imported drugs registration of, and local biotech companies in innovative drug registration.
• Extensive and could be proved successful experience in registration strategy.
• Familiar with the R&D process of innovative drugs, clinical trials, registration, and quality management systems, with an understanding of the domestic and foreign pharmaceutical industry and related industry policies and knowledge.