RA Specialist
9000元以上
上海
應(yīng)屆畢業(yè)生
學(xué)歷不限



- 全勤獎(jiǎng)
- 節(jié)日福利
- 不加班
- 周末雙休
職位描述
該職位還未進(jìn)行加V認(rèn)證,請(qǐng)仔細(xì)了解后再進(jìn)行投遞!
1. Principal Duties and Responsibilities (General Summary , essential functions and authorities, etc.)
主要工作職責(zé)(基本概況,主要功能,權(quán)限等)
I. Registration
注冊(cè):
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(jì)劃:充分了解指定產(chǎn)品的注冊(cè)計(jì)劃(新注冊(cè)/延續(xù)注冊(cè)/變更注冊(cè)/其他注冊(cè)事項(xiàng))和主管確定的注冊(cè)工作優(yōu)先次序;知道如何按季度/月/周/天執(zhí)行計(jì)劃;經(jīng)常跟蹤計(jì)劃實(shí)施狀態(tài)
b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略:對(duì)注冊(cè)路徑、分類、時(shí)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(zé)(基本概況,主要功能,權(quán)限等)
I. Registration
注冊(cè):
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(jì)劃:充分了解指定產(chǎn)品的注冊(cè)計(jì)劃(新注冊(cè)/延續(xù)注冊(cè)/變更注冊(cè)/其他注冊(cè)事項(xiàng))和主管確定的注冊(cè)工作優(yōu)先次序;知道如何按季度/月/周/天執(zhí)行計(jì)劃;經(jīng)常跟蹤計(jì)劃實(shí)施狀態(tài)
b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略:對(duì)注冊(cè)路徑、分類、時(shí)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(diǎn)
地址:上海徐匯區(qū)徐匯區(qū)桂菁路65號(hào)新研大廈


職位發(fā)布者
菅先生HR
強(qiáng)生(上海)醫(yī)療器材有限公司

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制藥·生物工程
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500-999人
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股份制企業(yè)
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上海市虹橋路355號(hào)城開國(guó)際大廈4樓
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