副研究員/研究員，工藝研發

Responsibilities

• Prepare process R&D related documents and reports to support IND and NDA.
• Update technical documents and effectively communicate with process R&D team.
• Support process R&D team to provide documentation for IND, NDA, IMPD, DSUR, annual report and etc.
• Work effectively with regulatory, analytical R&D, formulation R&D to support all related documents preparation and updates.

Qualifications

• Bachelor or Master degree in chemistry or pharmaceutical science.
• Good understanding on process chemistry, pharmaceutical science, drug development.
• Good English oral and writing skills.
• Familiar with CFDA/FDA/EMA regulations and ICH guidelines, previous experiences with global filings are preferred.

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