- 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(guó)監(jiān)管機(jī)構(gòu)提交申請(qǐng)。 -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(guó)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(píng)估等。 -應(yīng)了解生產(chǎn)/包裝工藝。 -負(fù)責(zé)協(xié)調(diào)與中國(guó)監(jiān)管相關(guān)的外部培訓(xùn)。 -負(fù)責(zé)協(xié)調(diào)現(xiàn)場(chǎng)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(guó)監(jiān)管要求。