Regulatory Affairs Manager (China)

position overview

Position: Regulatory Affairs Manager (RA )/ 规 事务经理(RA)

Job Location : China
Job Type: Permanent Full-time

We are searching for an experienced RA Manager for our office in China. The successful candidate should have strong regulatory and management skills, have worked and interacted with CFDA on many occasions and have registered a variety medical devices and drugs in China. The RA Manager will be responsible for China regulatory submissions to NMPA for Drugs and Medical Devices.


我们公司中国办公室在招聘一位有经验的法规事务经理。成功的候选人应具有较强的监管和管理技能,曾多次与CFDA合作互动,并在中国注册了多种医疗器械和药品。法规事务经理将负责就药品和医疗器械向国家药品监督管理局(NMPA )提交中国监管文件。


  • Plans, develops and applies regulatory strategies for the registration of drugs/pharmaceuticals in China.
  • Provide expertise in Chinese regulatory affairs leading to the successful regulatory registrations and approvals/registrations/licenses of drugs in China.
  • Be the main contact with CFDA on behalf of Global Regulatory Partners.
  • Be in charge of all compliance activities as required by CFDA.
  • Ensure the accurate and timely preparation of regulatory submissions and reporting of safety events to CFDA.
  • Communicate to GRP on regular basis any updates in Chinese regulations on drugs in China.
  • Report on regular basis to GRP the progress made on the registration of products in China.
  • Manage lifecycle management activities such as CAPAs, labeling, audit preparation and support, promotional and advertising review, technical file/design dossier updates
  • Participate and provide regulatory guidance and support to cross-functional teams
  • This position will include participation on New Product Development (NPD) teams to provide regulatory guidance and to obtain rapid and timely clearance of new products.
  • Review and analyze technical data generated by Research and Development, Marketing/Sales, Quality Assurance and other related departments
  • Evaluate changes in regulatory environment and standards
  • Conduct gap analysis and implementation plans to assure compliance to latest requirements.
  • Manage day to day activities and RA team.


  • 规划、制定和应用中国药品/药品注册的监管策略
  • 提供中国监管事务方面的专业知识,从而在中国成功进行药品监管注册和批准/注册/许可
  • 是全球法规合作公司与中国CFDA主要联系人
  • 负责CFDA 要求的所有法规活动
  • 确保准确、及时地准备向CFDA 提交监管文件和安全事件报告
  • 定期向GRP 通报中国药品法规的任何更新
  • 定期向GRP 报告产品在中国注册的进展情况
  • 管理生命周期管理活动,例如 CAPA、标签、审计准备和支持、促销和广告审查、技术文件/设计档案更新
  • 参与并为跨职能团队提供监管指导和支持
  • 参与新产品开发 (NPD) 团队提供监管指导并快速及时地获得新产品的批准
  • 审查和分析研发、营销/销售、质量保证和其他相关部门生成的技术数据
  • 评估监管环境和标准的变化
  • 进行差距分析和实施计划以确保符合最新要求
  • 管理日常活动和法规管理(RA) 团队


  • A Bachelor’s degree in a scientific discipline and an advanced degree
  • Experience working with professional, and trade medical device or drug associations is a plus.
  • Have a minimum of 6 years of experience in regulatory affairs in China.
  • Have a minimum 4 years of management experience.
  • Have compiled, submitted and registered many pharmaceutical products in China.
  • Have compiled and submitted successfully many CTA (Clinical trial Applications ) to CFDA.
  • Have interacted with CFDA on multiple occasions.
  • Should speak and write English fluently.
  • Have the ability to work independently with minimum supervision.
  • Have good work ethics.
  • Have an MBA is preferable.
  • Successful experience taking a product through the development and regulatory cycle domestically is required
  • Excellent oral and written communication skills are required
  • Experience with multi-site organization is preferred
  • Proven leadership and project management skills are desired
  • A successful track record coordinating and interacting with multiple cross-functional teams is desired.


  • 理科本科以及以上学历
  • 有与专业和贸易医疗器械或药物协会合作的经验者优先
  • 在中国有至少6年以上法规管理经验
  • 至少4年以上管理经验
  • 在中国编译,提交和注册过很多药物产品
  • 成功向中国药品监督管理局编译和提交很多临床试验申请
  • 能与国家药品监督管理局沟通互动
  • 中英文流利
  • 有独立的工作能力
  • 有良好的职业道德
  • 工商管理硕士者优先
  • 有在国内开发和监管周期中获得产品的成功经验者优先
  • 需要有出色的口头和书面沟通技巧
  • 有多站点组织经验者优先
  • 需要有经过验证的领导能力和项目管理技能者优先
  • 需要有与多个跨职能团队协调和互动的成功记录者优先


  • Minimum Experience Level: 6-years
  • Career Level: Mid-Career
  • Minimum English Level: Daily Conversation
  • Minimum Mandarin Level: Native
  • Minimum Education Level: Bachelor’s Degree
  • Visa Status: Permission to work in China required
  • Age Limit:  (No Age limit for applicants)


  • 最低1-4年相关经验
  • 中期职业生涯
  • 最低的英文水平可以达到日常对话
  • 母语是普通话
  • 最低本科学历
  • 有中国签证,可以在中国自由工作
  • 没有年龄限制


  • 工作类型:永远全职职位
  • 可以远程或现场工作


  • 公司类型:国际CRO
  • 公司总部:美国
  • 中国办事处: 上海,北京

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