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Johnson & Johnson

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Director, APAC, Regulatory Affairs, Hematology

CN · Beijing · Beijing, China · Hybrid in China · Full-time · Lead

需适配亚太及全球团队工作时区

NewMandarin neededHybrid in ChinaLead / managementOpen to China
Regulatory StrategyHealth Authority ComplianceCross-functional Team LeadershipProduct RegistrationRegulatory IntelligenceStakeholder Management

Salary not stated

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AI summary

About the company

强生是全球医疗健康领域龙头企业，业务覆盖创新药与医疗科技，致力于通过创新解决方案预防、治疗、治愈复杂疾病，秉持企业信条为全球员工提供包容的工作环境。

Role overview

该岗位为强生全球法规事务团队的亚太区区域法规负责人，驻北京，全职混合办公。负责制定并执行亚太区血液学领域产品的区域法规战略，协调全球及本地团队，管理法规事务团队，推动产品注册、上市及生命周期管理，适配亚太业务与研发目标。

Responsibilities

  • 制定并执行亚太区血液学产品的区域法规战略
  • 协调全球及本地团队推进产品注册与上市
  • 管理法规事务团队，负责预算、绩效与合规
  • 跟踪区域法规要求变化，提供法规情报
  • 对接卫生监管机构，准备并参与监管会议
  • 协调亚太区各国法规事务优先级与资源
  • 支持产品生命周期内的标签变更、许可续期等
  • 与本地制造站点协作确保注册所需包装合规

Requirements

  • 具备10年以上法规事务相关经验，含亚太区域经验
  • 熟悉全球及亚太各国药品注册法规与流程
  • 具备团队管理与跨部门协作能力
  • 具备战略规划与问题解决能力
  • 良好的中英文沟通能力
  • 本科及以上学历，医药相关专业优先

Nice to have

  • 血液学领域专业背景
  • 生物制品或仿制药法规经验
  • 跨国药企法规事务经验
  • 具备卫生监管机构对接经验

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Excerpt

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative…

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Sources

  • 公司官方招聘页· today
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Director, APAC, Regulatory Affairs, Hematology · Johnson & Johnson · Global Search | Fintegrity