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Regulatory Affairs Group

RA Specialist

  • Título RA Specialist
  • Función Regulatory Affairs Group
  • Sub función Regulatory Affairs
  • Categoría Analyst, Regulatory Affairs (P4 - E24)
  • Ubicación Shanghai, China
  • Publicado
  • Identificación requerida (Req ID) 2406190416W
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Descripción

I.         Registration
注册:

a)        Plan: Well know assigned products' registration plan (new/renewal/change/others) and prioritization defined by supervisor; know how to execute the plan by quarter/month/week/day; frequently track the implementation status
计划: 充分了解指定产品的注册计划(新注册/延续注册/变更注册/其他注册事项)和主管确定的注册工作优先次序;知道如何按季度/月/周/天执行计划;经常跟踪计划实施状态

b)        Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略: 对注册路径、分类、时间表、审查偏好有基本了解……

c)        Execute: compile the registration dossier per most updated NMPA requirements; order sample and follow type testing, to meet registration timeline; prepare eRPS submission and complete payment by due; closely track status in CMDE; handle reviewers questions and provide supporting documents per request; complete filling & database accurately input after approval
执行: 根据中国国家药品监督管理局(“NMPA”)的最新要求编制注册申报资料;订购样品并进行型式测试,以满足注册时间表的要求;编写eRPS注册申报文件并按时完成付款;密切跟踪中国国家药品监督管理局医疗器械技术审评中心(“CMDE”)显示的注册状态;处理审评员提出的问题并根据要求提供支持文件;获批准之后填写相关表格并准确录入数据库

II.        Communication & escalation: clearly describe the questions/needs, timely ask WWBU RA for documents & support; communicate with China cross function members on registration status; clearly communicate with reviewers on dossier contents; frequently communicate with supervisor to report progress and escalate risks/issues.
沟通与上报: 清晰描述问题/需求,及时向全球业务部门法规事务部(WWBU RA)索取文件和支持;与中国跨职能团队成员就注册状态进行沟通;与审评员就注册申报资料的内容进行清晰沟通;经常与主管沟通,以报告工作进度并上报风险/问题。

III.      Post Market Compliance: maintain related database accurately; execute routine after-approval processes e.g. Chinese labeling, copy review etc ; timely assess change notification of LCM products, trigger necessary registration activities immedicately; support post market actions e.g. audit, inspection, recall…
上市后合规性: 准确维护相关数据库;执行例行的批准后流程,例如贴中文标签、文案审查等;及时评估LCM产品的变更通知,立即触发必要的注册活动;支持上市后举措,例如审核、检验、召回……

IV.      Process Excellence: follow company SOP/WI/guidance on routine processes; think about improvement & speak out ideas
流程优化: 遵循公司标准操作程序(SOP)/作业指导书(WI)/常规流程指南;思考改进并提供思路

V.       Policy shaping: Curiosity and passion for new regulation, policy, standards and technologies; be aware of NMPA/CMDE/Lab common working processes; correctly interpret key regulatory requirements by self learning or participating training, and deliver to WWBU RA & other function members.
政策思维塑造: 对新法规、政策、标准和技术怀有好奇心和热情;了解NMPA/CMDE/实验室常见工作流程;通过自学或参与培训正确解读关键法规要求,并传授给全球业务部门法规事务部和其他职能部门的成员。

VI.      know JNJ & BU routine operation
了解强生与业务部门(“BU”)的常规业务操作

VII.    build up basic self management skills, project management, time management, presentation, etc; good sharing & teaming spirit; actively absorb knowledge from others & trainings
塑造基本的自我管理技能、项目管理、时间管理、演示宣讲等技能;具有良好的分享和团队精神;积极吸收来自他人传授和从培训中获得的知识

Other responsibilities defined in written procedures.

流程中规定的其它职责。

Calificaciones

基本任职资格(包括教育背景和 / 或知识和 / 或培训和 / 或相关工作经验)

I.   Education Background: B.S. or above; Prefer in medical, material, mechanical/biomechanical engineering or pharma
教育背景: 理学学士或以上学历水平;首选医学、材料学、机械学/生物力学工程或制药学专业

II.   Work experiences: Prefer 1~3 years experiences before joining JNJ
工作经验: 加入强生前有1~3年相关工作经验者优先

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