高级药品注册专员Senior Regulatory Affairs 上海

月薪： 15-20万/年

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 员工旅游
  • 通讯补贴
  • 专业培训
  • 出国机会
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： Key Job Responsibilities: Provide regulatory consultation for in-house clinical projects or stand-alone regulatory projects Compile and submit INDs/CTAs and NDAs/MAAsConduct QC reviews of regulatory documents, such as Investigators’ Brochure Remain current with changing regulatory requirementsResponsible for post marketing registration, new product registration, product license renewal, registration changes and trial application, including prepare registration dossiers correctly and timely. Have a good understanding of Chinese regulatory environment. Implement regulatory activities as required by governmental regulations and internal SOPs. Follow up the registration process, and communicate with SFDA, CDE and other governments or departments effectively.Job Qualifications: Bachelor or above degree, preferably in life science or related course 5 year drug registration experience in pharmaceutical industry Good understanding of local regulations, guidelines and requirements and have experience in preparation of submissions. Good English skills both in written and oral. Proficiency in Excel and other MS office tools. Good communication skills with cooperators and colleagues. 职能类别： 药品注册 关键字： Regulatory Affairs

联系方式

上海市静安区南京西路688号506

公司信息

InVentiv Health通过分布在全球70多个国家的14000名员工，为医药、医疗器械和生物工程客户提供临床研发、销售及商务咨询服务，inVentiv Health的目标是通过自身的专业服务将客户的商业理念真正地转化为现实，帮助客户提升业绩，现在inVentiv Health服务于约550家客户的850个品牌。 2011年12月，inVentiv Health在中国设立盈帆达医药咨询（上海）有限公司，正式在中国区域为医药行业客户提供服务。 inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bio-analytical services, and strategic resourcing from a single clinical professional to an entire functional team.

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