Director/Senior Director, Regulatory Affairs

1. Responsible for the formulation of global CMC registration strategy for the project, and support the global registration declaration; 2. Quality control of project CMC application data; 3. Provide registration consulting services, regulation interpretation and training; 4. Responsible for the construction of registered Reg CMC platform system, including declaration standards, GAP analysis, document system, etc.

Education and major: Bachelor degree or above, major in biology or pharmacy. Professional knowledge: Proficient in Chinese, American and European registration regulations and technical guidelines; Proficient in CMC Regulation. Work experience: At least 5-10 years of international registration experience, with successful product declaration experience; Understand the international application and registration of biological drugs, chemical drugs and ADC; Skills: Fluent in English, reading and writing; Other requirements: Excellent organizational communication and coordination skills.