RA Senior Specialist - 00001KTL

Description

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。

Qualifications

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 35 years experiences before joining JNJ

工作经验： 加入强生前有35年相关工作经验者优先

Primary Location Asia Pacific-China-Shanghai-Shanghai

Organization Johnson & Johnson Medical Shanghai Ltd. (7055)

Job Function Regulatory Affairs

Req ID: 00001KTL