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/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.
-負責向中國監(jiān)管機構提交申請。
-協(xié)調與CFDA/其他監(jiān)管機構所有活動（提交、GMP審計、審計回復提交和合規(guī)、續(xù)期等）
-負責確認中國藥典規(guī)范/要求等的合規(guī)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(xié)調與中國監(jiān)管相關的外部培訓。
-負責協(xié)調現(xiàn)場合規(guī)、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(jiān)管要求。
