Specialist, Regulatory Affairs

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:

Principal Duties and Responsibilities (General Summary, essential functions and authorities, etc.) 
主要工作职责（基本概况，主要功能，权限等） 

法规事务专员由其直线经理监督管理。法规事务专员负责多个法规事务项目的计划、执行和交付，以实现公司重大目标。法规事务专员负责在直线经理的监督管理下计划并执行所分配项目的注册工作；负责协调不同跨职能部门之间的工作，包括研发、生产、质量、医学事务、临床、法务以及其他职能部门，以满足项目注册之需要。本职位要求具备相应的法规和产品知识、一定的协调能力、沟通能力与执行能力，这些都会直接影响业务部门的运营结果。 
RA Specialist is under the supervision from their line manager.

They will be responsible for planning, execution, and delivery of multiple RA projects to achieve significant company goals.

RA Specialist plan and execute the registration activities for assigned projects under their line manager’s supervision.

They coordinate activities of various cross-functional departments including research & development, manufacturing, quality, medical, clinical, legal, and other functions to meet the needs of project registration.

This role requires regulation and product knowledge, coordination, communication skills and execution which directly impact the operational results of the business unit. 

主要职责/任务（以时间的百分比表示）： 
Key responsibilities/tasks （indicate estimated % of time spent where possible）： 
70%  产品注册准备和执行。 
70%  Product registration preparation & execution. 
10%  制定注册项目计划。 
10%  Develop registration project plan. 
10%  为法规合规工作提供支持。 
10%  Support regulatory compliance activities. 
10%  法规信息收集、解读和政策制定。 
10%  Regulatory intelligence collection, interpretation and policy shaping. 

职责/主要衡量指标： 
Accountabilities/Key measures： 

根据注册（以及延续注册）策略和注册项目计划，计划并执行项目注册工作。 
Plan and execute project registration activities according to the registration (and ...