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浏览次数:1  Associate Regulatory Affairs Director (P4), China
 行业  管理类  职位  管理类
 招聘部门    招聘人数  1人
 工作地区  北京  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

Job Title: Associate Regulatory Affairs Director (P4), China
Division: Lilly China Medical & Regulatory Affairs
Reports to: Regulatory Affairs Director (RAD), China

Key Task Areas:

1. Assisting RAD in Regulatory and Business Planning
2. Developing regulatory strategy for responsible TA products
3. Regulatory project management
4. Recruiting, supervising, training and developing team members.
5. Contribute to local GRP construction

Responsibilities:

• Provide regulatory leadership, expertise & value in strategic planning, and get alignment from TA core team task force to accelerate the submission, approval & launch of responsible TA new pipeline (new molecules, indications & line extensions) to improve patient outcomes in China
• Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through operational excellence.
• Ensure product registration and perform regulatory affair activities under Lilly’s policies and standard operating procedures, and other applicable laws and regulations.
• Communicate with regulatory agencies/institutes (e.g., SFDA, CDE, NICPBP, coast drug control institute) and Lilly internal departments on product registration issues.
• Monitor and evaluate the new regulations/guidance, regulatory changes/trends, and communicate with internal stakeholders under the direction of RAD.
• Participate in the construction of GRP in RA team.
• Cross-functional
- Provide input and advice on the new product launch plan in terms of regulatory requirement.
- Collaborate with related functions to ensure market supply sufficient, artwork and labeling comply with agency requirement and marketing promotion needs.

• Perform ad hoc projects or assignments.

Qualification:

1. At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences
2. At least 8-years experience in drug regulatory affairs with at least 3-year supervisor experience in global leading pharmaceutical company
3. Good command of English writing, speaking and listening skill
4. Self-motivated and Innovative
5.
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。




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