职位&公司对比

职位详情

• 泰州
• 10年以上
• 本科

• 良好的英文能力
• 药学相关专业
• 化学药
• QA
• 生产工艺
• 法规QA

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, renewalBOSS直聘s etc…). - Responsible for verification of Chinese pharmacopeial compliance of specificbossations/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 coo来自BOSS直聘rdination of External trainings related to Chinese regulatory. - Responsible to coordination with Site regulatory, production, administration, QC etc.. teams to ensure/collect the required information/docbossuments etc.. - Responsible to ensure the Chinese language terminologies/requirements for documents aligned for Chinese regulatory. -负责向中国监管机构提交申请。 -协调与CFDA/其他监管机构所有活动（提交、GMP审计、审计回复提交和合规、续期等） -负责确认中国药典规范/要求等的合规性等 -应能够为产品准备工来自BOSS直聘艺流程图、共线评估等。 -应了解生产/包装工艺。 -负责协调与中国监管相关的外部培训。 -负责协调现场合规、生产、行政、质量控制等团队，确保/收集所需的信息/文件等。 -负责确保文件的中文术语/要求符合中国监管要求。