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崗位描述：
根據(jù)國(guó)內(nèi)外法規(guī)指南（尤其中美法規(guī)指南）相關(guān)要求，撰寫或?qū)徍薈TD資料
理解并應(yīng)用法規(guī)指南，及其對(duì)注冊(cè)申報(bào)和上市前及上市后的影響
策劃、執(zhí)行和管理注冊(cè)申報(bào)事務(wù)，包括INDs、CTAs/IMPDs、NDAs和ANDAs
審閱技術(shù)報(bào)告，并參與項(xiàng)目申報(bào)策略討論
與公司同事分享從項(xiàng)目中獲得的知識(shí)經(jīng)驗(yàn)
熟練運(yùn)用eCTD尤佳
任職資格：
藥學(xué)或其它生命科學(xué)學(xué)士學(xué)位本科以上學(xué)歷
有1年以上注冊(cè)法規(guī)工作經(jīng)驗(yàn)者優(yōu)先
注重細(xì)節(jié)且處事靈活，可有效處理緊急和大量工作
良好的時(shí)間管理技能
熟練運(yùn)用電腦、MS Word、Excel和PowerPoint
英語聽說讀寫流利
Job Description
In this role you are responsible for prepare or review CTD dossiers according to current domestic and global regulatory requirements, specifically China and US markets
Understands and applies regulatory requirements and their impacts for submissions and pre- and post-market compliance
Plans, executes, and manages regulatory submissions including INDs, CTAs/IMPDs, NDAs and ANDAs
Provide inputs in technical reviews and strategic discussions on regulatory submissions
Share knowledge and learnings gained from own projects with colleagues within and outside the department as appropriate
Familiar with eCTD is preferable
Qualifications
Bachelor's degree or above in pharmaceutical or other life science
A minimum of 1 years’ experience in regulatory affairs is preferable
Attention to detail and a flexible attitude enough to successfully handle conflicting time pressures and a large volume of work
Good time management skills
Computer literate and advanced MS Word, Excel and PowerPoint
Fluent in English, written and spoken