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崗位描述： 根據(jù)國內(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，及其對注冊申報和上市前及上市后的影響 策劃、執(zhí)行和管理注冊申報事務(wù)，包括INDs、CTAs/IMPDs、NDAs和ANDAs 審閱技術(shù)報告，并參與項目申報策略討論 與公司同事分享從項目中獲得的知識經(jīng)驗 熟練運用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年以上注冊法規(guī)工作經(jīng)驗者優(yōu)先 注重細節(jié)且處事靈活，可有效處理緊急和大量工作 良好的時間管理技能 熟練運用電腦、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