1. 參與注冊(cè)項(xiàng)目的計(jì)劃、準(zhǔn)備及執(zhí)行,確保項(xiàng)目成功注冊(cè); 2. 編制注冊(cè)申請(qǐng)資料并準(zhǔn)備其他法規(guī)文件,確保經(jīng)內(nèi)部審閱和批準(zhǔn)之后的資料及時(shí)遞交; 3. 維護(hù)注冊(cè)文件的存檔; 4. 關(guān)注法規(guī)的變化,確保所提交的資料是符合法規(guī)要求的并且適用于不斷變化的法規(guī)。 1. Plan, prepare, and execute regulatory submissions for clinical trials and drug registrations. 2. Compile and submit regulatory documents, ensuring compliance with the latest requirements. 3. Archive and maintain regulatory documents and files. 4. Stay up-to-date with regulatory changes and ensure submission materials are compliant with evolving regulations.
任職要求
1. 教育背景:藥學(xué)或醫(yī)學(xué)相關(guān)專業(yè)碩士及以上學(xué)歷; 2. 工作經(jīng)驗(yàn):1-3年CRO或制藥公司工作經(jīng)驗(yàn),第三方實(shí)驗(yàn)機(jī)構(gòu)或注冊(cè)工作經(jīng)驗(yàn)優(yōu)先; 3. 專業(yè)技能:擅長(zhǎng)文案工作,對(duì)相關(guān)注冊(cè)法規(guī)有一定的了解; 4. 語(yǔ)言能力:具有較好的中英文口語(yǔ)/書(shū)面溝通能力; 5.其他條件:熟練掌握計(jì)算機(jī)操作,熟練掌握Office辦公軟件。 1. Education: Master’s degree in Pharmacy, Medicine or related fields. 2. Experience: 1-3 years of experience in regulatory affairs, preferably within a CRO or pharmaceutical company. 3. Skills: Strong writing and document preparation skills; good understanding of regulatory guidelines. 4. Language: Fluent in both Chinese and English Speaking and Writing. 5. Other: Good at office suites.