Director/Senior Director, Regulatory Affairs
15000 CNY~20000 CNY/Per month
Full-time
5~10 years
Refresh at 3 months ago
238 Views
46 Apply
Shanghai
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Job responsibilities
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.
Job Requirements
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.
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