職位描述
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Principal Duties and Responsibilities (General Summary , essential functions and authorities, etc.)
主要工作職責(基本概況,主要功能,權限等)
I. Registration 注冊:
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
計劃:充分了解指定產品的注冊計劃(新注冊/延續注冊/變更注冊/其他注冊事項)和主管確定的注冊工作優先次序;知道如何按季度/月/周/天執行計劃;經常跟蹤計劃實施狀態
b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略:對注冊路徑、分類、時間表、審查偏好有基本了解……
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
主要工作職責(基本概況,主要功能,權限等)
I. Registration 注冊:
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
計劃:充分了解指定產品的注冊計劃(新注冊/延續注冊/變更注冊/其他注冊事項)和主管確定的注冊工作優先次序;知道如何按季度/月/周/天執行計劃;經常跟蹤計劃實施狀態
b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略:對注冊路徑、分類、時間表、審查偏好有基本了解……
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
工作地點
地址:上海徐匯區徐匯區桂菁路65號新研大廈
