岗位职责：

This position is responsible for providing expertise and/or leadership for China CMC regulatory activity of biological drug (and/or chemical drug as required) in the portfolio. Representing RACMC on cross- functional project teams, this individual will work on developing and executing phase-appropriate CMC regulatory strategies, reviewing CMC information and data, authoring CMC submissions, and interacting with Health Authorities to meet the aggressive urgent submission timelines for the assigned projects, interacting with China national testing agency (e.g NIFDC). The individual will also contribute to regulatory process optimizations on relevant topics.

资历要求：

- Minimum of 5 years of experience in the pharmaceutical industry, and minimum of 2 years of experience in global RACMC with emphasis on late stage CMC drug development and marketing authorization applications on chemical drug and/or biologics in China.

- Prefers analytical background for QC testing support, with good understanding of Chinese Pharmacopeia requirements, especially biological analysis or Chemical product analysis background.

- Successful track record in preparation, management of review and approval of IND/BLA/NDA with Health Authority, with writing ability for China specific documents. Prefer having experience of working in global environment in interdisciplinary teams.

- Bachelor degree or above in Life Science or Pharmacy.

- Excellent written and oral communication skills in English.