Innovent Biologics(X) Logo
Innovent Biologics(X) Logo
Director/Senior Director, Regulatory Affairs
Full-timeNegotiableShanghai
Innovent Biologics(X)
Refresh at 21 days ago 130 views

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.

Required Languages

Mandarin, English

Job Details

Position type

Other

Experience

5~10 years

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