职位描述
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1. Principal Duties and Responsibilities (General Summary , essential functions and authorities, etc.)
主要工作职责(基本概况,主要功能,权限等)
I. Registration
注册:
a) Plan: Well know assigned products' registration plan (new/renewal/change/others) and prioritization defined by supervisor; know how to execute the plan by quarter/month/week/day; frequently track the implementation status
计划:充分了解指定产品的注册计划(新注册/延续注册/变更注册/其他注册事项)和主管确定的注册工作优先次序;知道如何按季度/月/周/天执行计划;经常跟踪计划实施状态
b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略:对注册路径、分类、时间表、审查偏好有基本了解……
c) Execute: compile the registration dossier per most updated NMPA requirements; order sample and follow type testing, to meet registration timeline; prepare eRPS submission and complete payment by due; closely track status in CMDE; handle reviewers questions and provide supporting documents per request; complete filling
主要工作职责(基本概况,主要功能,权限等)
I. Registration
注册:
a) Plan: Well know assigned products' registration plan (new/renewal/change/others) and prioritization defined by supervisor; know how to execute the plan by quarter/month/week/day; frequently track the implementation status
计划:充分了解指定产品的注册计划(新注册/延续注册/变更注册/其他注册事项)和主管确定的注册工作优先次序;知道如何按季度/月/周/天执行计划;经常跟踪计划实施状态
b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略:对注册路径、分类、时间表、审查偏好有基本了解……
c) Execute: compile the registration dossier per most updated NMPA requirements; order sample and follow type testing, to meet registration timeline; prepare eRPS submission and complete payment by due; closely track status in CMDE; handle reviewers questions and provide supporting documents per request; complete filling
工作地点
地址:上海徐汇区徐汇区桂菁路65号新研大厦
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职位发布者
菅先生HR
强生(上海)医疗器材有限公司
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制药·生物工程
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500-999人
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股份制企业
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上海市虹桥路355号城开国际大厦4楼