CMC RA Lead – 瓴路药业 |
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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 |
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