RA Specialist

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 Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Beijing, China, Shanghai, China

Job Description:

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,...