人才招募
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上海, 藥物研究與發展 | 2020-05-21

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.