職位描述
職位類別：醫(yī)療 | 制藥 | 環(huán)保/制藥/生物工程/醫(yī)藥研發(fā)/生產(chǎn)/注冊
- Responsible for submission of applications to China regulatory authorities.
- Coordination with CFDA/other regulatory authorities related to all activities (submission, GMP audit, audit response submission and compliance, renewals etc…).
- Responsible for verification of Chinese pharmacopeial compliance of specifications/requirements etc...
- Should be able to prepare process flow chart, collinear assessments etc… for the products.
- Should have knowledge on manufacturing/packing process.
- Responsible for coordination of External trainings related to Chinese regulatory.
- Responsible to coordination with Site regulatory, production, administration, QC etc.. teams to ensure/collect the required information/documents etc..
- Responsible to ensure the Chinese language terminologies/requirements for documents aligned for Chinese regulatory.
-負(fù)責(zé)向中國監(jiān)管機(jī)構(gòu)提交申請。
-協(xié)調(diào)與CFDA/其他監(jiān)管機(jī)構(gòu)所有活動(dòng)（提交、GMP審計(jì)、審計(jì)回復(fù)提交和合規(guī)、續(xù)期等）
-負(fù)責(zé)確認(rèn)中國藥典規(guī)范/要求等的合規(guī)性等
-應(yīng)能夠?yàn)楫a(chǎn)品準(zhǔn)備工藝流程圖、共線評估等。
-應(yīng)了解生產(chǎn)/包裝工藝。
-負(fù)責(zé)協(xié)調(diào)與中國監(jiān)管相關(guān)的外部培訓(xùn)。
-負(fù)責(zé)協(xié)調(diào)現(xiàn)場合規(guī)、生產(chǎn)、行政、質(zhì)量控制等團(tuán)隊(duì)，確保/收集所需的信息/文件等。
-負(fù)責(zé)確保文件的中文術(shù)語/要求符合中國監(jiān)管要求。
