CMC RA Lead

岗位名称: CMC RA Lead

汇报岗位: CEO

部门：Regulatory Affairs

工作地点：Shanghai

岗位概述
Provide regulatory CMC assessments and supports to BD projects, IND strategy and BLA filing.

工作职责

  • Provide regulatory CMC assessment in terms of CMC challenge and potential impacts on the development timeline for BD Projects
  • Provide regulatory CMC supports on the China IND strategy, identify potential gaps btw CDE requirements and available data, establish CMC development strategy in early phase and IND submission timeline
  • Provide regulatory CMC supports during China development process and ensure timely CN BLA or NDA filing and approval via establishing and implementing the CMC development strategy and plan
  • Provide regulatory CMC supports to research projects to ensure clear CMC research strategy in place

相关工作经验要求

  • 5+ years Biology R&D works
  • 3+years Regulatory CMC works in MNC or Bio-pharm or Biotech
  • 1+ year CDE work experience preferred

必要的学历和专业资格，含语言能力

  • Biology Education background, PhD is preferred

必要的技能和能力

  • Strong Biology background
  • Strong communication skill
  • Fluent English skill in both speaking and writing
  • Experience in cross-functional collaboration
  • Strong regulatory sense and expertise in biologic CMC