RA Specialist

Develops skill set to enable value added individual contributions, who works under close supervision. Applies methods for planning, directing, coordinating and controlling regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations to ensure compliance with regulatory/ government standards.

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

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

Travel: