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
求职提示:用人单位发布虚假招聘信息,或以任何名义向求职者收取财物(如体检费、置装费、押金、服装费、培训费、身份证、毕业证等),均涉嫌违法,请求职者务必提高警惕。
职位发布者
菅先生HR
强生(上海)医疗器材有限公司
- 制药·生物工程
- 500-999人
- 股份制企业
- 上海市虹桥路355号城开国际大厦4楼