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浏览次数:1  Manager, China Regulatory Affairs
 行业  管理类  职位  管理类
 招聘部门    招聘人数  1人
 工作地区  上海  工作性质  全职
 性别要求  不限  婚姻要求  不限
 学历要求  本科  工作经验  5年以上
 年龄要求  28岁以上  待遇水平  面议
 更新日期  2013-07-17  有效期至  长期有效
 职位描述
Job Description
Position: Manager, China Regulatory Affairs
Division/Department: Regulatory Affairs and Clinical development
Location: Beijing/Shanghai, China
Report to: Director of Regulatory Affairs


Key Responsibilities:
Develop regulatory strategy and action plan for internal or external projects, in compliance with local regulations, and guidelines and SOPs.
Compile registration dossier and ensure timely regulatory submission. Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration.
Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
Collaborate closely with internal groups and external clients in developing R&D strategies and/or commercial strategies.
Provide regulatory expertise to the BD projects.
Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., SFDA, CDE, NICPBP, Provincial FDAs, Coast Drug Control Institutes).
Continuously monitor the development of regulations and policies of healthcare and pharmaceutical products, and ensure the potential impact to projects or company business have been thoroughly evaluated and well communicated.


Qualification:
Medical/pharmacy/life sciences background, B.S. or above
Over 5 years regulatory experience in a globe leading pharmaceutical company
Strong network with regulatory agencies, e.g. CDE, SFDA, NICBPB
Be familiar with regulations and guidelines in SFDA, SFDA and EU
Excellent communication skills and convincing skills in both Chinese and English
Good leadership and project management skills
Good team player
Open attitude, Willing to meet challenges


Note: The statements made here are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job
感兴趣的朋友请直接联系0755-86664693,或者把简历发到hlongmedhunting@gmail.com
了解更多信息:http://www.hlongmed.com/hr.asp?i=1



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 公司介绍

深圳市龙德生物科技有限公司致力于为医疗器械生产商、经销商、医疗机构、行业监管及投资机构提供医疗器械咨询和产品服务的完整解决方案。公司的业务范围涵盖全球100多个国家(包括SFDA、FDA、CE、Canada、Brazil、Japan等)医疗器械运营、流程、研发、生产、质量、医疗器械临床试验咨询CRO、法规等医疗器械咨询、医疗器械注册代理、医疗器械多语言翻译以及行业信息研究。



深圳市龙德生物科技有限公司还为医疗器械生产企业和使用机构提供专业的桥梁服务,为医院和专业团体提供医疗产品和医疗方案以及全球采购服务,并为医疗器械生产商提供全球市场开拓和销售服务。



深圳市龙德生物科技有限公司是由多年从事医疗器械行业的资深专家组成,核心团队和合作伙伴来自北美、欧洲、中国等多个国家和地区。




我们深谙中国医疗器械法规监管!

我们熟知中小企业发展困惑!

我们精于全球市场开拓!

专业给您带来价值!


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