- 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. -負責向中國監管機構提交申請。 -協調與CFDA/其他監管機構所有活動（提交、GMP審計、審計回復提交和合規、續期等） -負責確認中國藥典規范/要求等的合規性等 -應能夠為產品準備工藝流程圖、共線評估等。 -應了解生產/包裝工藝。 -負責協調與中國監管相關的外部培訓。 -負責協調現場合規、生產、行政、質量控制等團隊，確保/收集所需的信息/文件等。 -負責確保文件的中文術語/要求符合中國監管要求。