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Regulatory Affairs Managers CV Example in Mandarin_chinese

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Theme: engineeringresumes · Language: mandarin_chinese
Regulatory Affairs Managers CV in Mandarin_chinese — page 1
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陈敏

简介

拥有10年法规事务经验，擅长中国医疗器械和药品注册、合规性策略制定及上市后监管。成功主导多项创新医疗器械和进口药品的NMPA注册，缩短审批周期并确保市场准入。精通法规解读、风险评估与跨部门协作，致力于为企业提供高效的法规解决方案。

在复杂法规环境下，通过精细化策略管理，成功应对并解决多起注册挑战，确保产品顺利上市。具备卓越的沟通协调能力，有效连接研发、生产与销售团队，确保产品全生命周期合规。

工作经历

高级法规事务经理, 广州华康生物科技有限公司 -- 广州, 中国

三月 2018 – 至今

  • 领导团队完成3个III类医疗器械和2个创新药品的NMPA注册，平均审批时间缩短15%。

  • 建立并优化公司法规事务管理体系，确保所有产品符合最新国家法规及技术审评要求。

  • 成功应对NMPA现场核查，确保公司无不符合项，维护了良好的企业合规记录。

  • 提供法规培训予研发、生产和质量部门，提高全员法规意识和执行力，减少潜在合规风险。

法规事务专员, 广东医药集团股份有限公司 -- 广州, 中国

九月 2013 – 二月 2018

  • 负责多个II类医疗器械和仿制药品的注册申报资料准备、提交及跟踪，确保资料完整性和准确性。

  • 协助经理与NMPA审评中心进行沟通，及时解决审评过程中出现的问题。

  • 跟踪国内外医疗器械及药品法规动态，定期汇报法规更新，为公司产品开发提供法规支持。

  • 参与公司质量管理体系（QMS）的建立与维护，确保符合GMP/GSP要求。

教育背景

中山大学, 药学 理学硕士 -- 广州, 中国

九月 2010 – 七月 2013

华南理工大学, 生物工程 工学学士 -- 广州, 中国

九月 2006 – 七月 2010

技能

法规专业知识: NMPA法规 (医疗器械、药品), GMP/GSP, GVP, ISO 13485, CE法规 (MDR/IVDR), FDA法规

注册申报: 医疗器械注册, 药品注册, 临床试验申请 (CTA), 上市许可申请 (MAA), 注册变更, 延续注册, 体系核查

法规策略: 市场准入策略, 合规性风险评估, 产品生命周期管理, 法规路径规划

项目管理: 跨部门协调, 供应商管理, 时间管理, 资源分配

软件工具: Microsoft Office Suite, 电子申报系统, 文档管理系统

语言: 普通话 (母语), 英语 (流利)

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Same CV in other languages

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