1. Be fully responsible for the registration dossier preparation and submission of assigned projects; Be responsible for timely order the registration sample, dossier, certificates;
2. Contribute to the discussion of registration plan with both local and global team;
3. Achieve the target timeline of submission and approval;
4. Track the registration status in CDE and NMPA and timely report to the line manager;
5. Organize to answer technical questions referred by HAs;
6. Coordinate of F2F discussion meeting with HAs;
7. Communicate with HQ about the issues related to the responsible product registration; for example dealing with relative issues on drug quality test in HA's lab;
8. Accountable for ensuring regulatory compliance for the responsible brands like CMC, CDS, PSUR, RMP, registration master file and timely update CPDS, systems like Insight, iMedidata and etc. ;
9. Responsible for artwork preparation and communicate with site or via Catalyst in time.
10. Monitor regulatory changes and report to line manager timely
11. Ensure regulatory activities comply with internal SOP for routine work
1. 全權(quán)負(fù)責(zé)所分配項目的注冊申報資料準(zhǔn)備與提交工作;負(fù)責(zé)及時申領(lǐng)注冊樣品、申報資料及相關(guān)證明文件。
2. 參與本地及全球團(tuán)隊關(guān)于注冊方案的討論。
3. 確保按時完成資料提交及審批的目標(biāo)時間節(jié)點。
4. 跟蹤藥品審評中心(CDE)及國家藥品監(jiān)督管理局(NMPA)的注冊進(jìn)度,并及時向直屬上級匯報。
5. 組織協(xié)調(diào)針對藥品監(jiān)管機(jī)構(gòu)(HAs)提出的技術(shù)問題進(jìn)行答復(fù)。
6. 協(xié)調(diào)安排與藥品監(jiān)管機(jī)構(gòu)(HAs)的面對面溝通會議。
7. 就所負(fù)責(zé)產(chǎn)品注冊相關(guān)事宜與總部(HQ)溝通,例如處理藥品監(jiān)管機(jī)構(gòu)實驗室中的藥品質(zhì)量檢測相關(guān)問題。
8. 負(fù)責(zé)確保所負(fù)責(zé)品牌的法規(guī)合規(guī)性,涵蓋化學(xué)、生產(chǎn)和控制(CMC)、臨床數(shù)據(jù)摘要(CDS)、定期安全性更新報告(PSUR)、風(fēng)險最小化計劃(RMP)、注冊主文件等;并及時更新臨床研究文檔管理系統(tǒng)(CPDS)、Insight、iMedidata等相關(guān)系統(tǒng)信息。
9. 負(fù)責(zé)包裝設(shè)計稿(artwork)的準(zhǔn)備工作,并及時與相關(guān)站點溝通或通過Catalyst(注:可能為特定溝通/管理系統(tǒng))進(jìn)行協(xié)調(diào)。
10. 關(guān)注法規(guī)政策變化,并及時向直屬上級匯報。
11. 確保日常所有法規(guī)相關(guān)工作均符合諾華內(nèi)部標(biāo)準(zhǔn)操作規(guī)程(SOP)。
工作要求:
藥學(xué)相關(guān)專業(yè)碩士畢業(yè),本科也可
2-3年及以上工作經(jīng)驗,藥品注冊相關(guān)工作經(jīng)驗
熟練英文工作,熟練使用辦公室軟件