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药品注册工程师

Amoytop Biotech · 福建省·厦门市·海沧区

Imported listingfull-time6 days ago

About The Role

  • 1.紧跟全球药品注册法规与政策、全球药品市场发展趋势及竞争格局等最新动态，分析其对项目的影响，制定并优化注册策略；
  • 2.深入研究全球各市场注册要求，主导项目的注册策略规划，解决注册过程中的技术难点和风险点，提供注册策略方面的专业指导和支持；
  • 3.负责国内外相关注册申报工作及相关资料的撰写、审核，建立和完善注册申报资料框架及模板，与国内外监管机构进行专业沟通；
  • 4.为注册项目提供全方位技术支持，参与技术学科建设与流程优化；
  • 5.参与部门内外部管理与协调
  • 1.硕士研究生，生物制药、生物工程、制药工程、药学、临床、药理或相关专业；
  • 2.CET6
  • 3.主持过临床/非临床模块注册文件撰写工作优先；
  • 4.主持过生物制品IND\NDA注册申报项目工作优先；
  • 6.对全球药品注册的法律法规有深入的理解，有较好的风险评估与管理能力；
  • 7.具有较好报告撰写能力，具备系统化思维逻辑，有不断探索创新精神。

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