• 5-7年经验
  • 硕士
  • 招2人
  • 12-21 发布

职位描述

Responsibility:1.Responsible for new product registration, product license renewal, registration changes and trial application, including prepare registration dossiers correctly and timely.2.Have a good understanding of Chinese regulatory environment.3.Implement regulatory activities as required by governmental regulations and internal SOPs.4.Follow up the registration process, and communicate with CFDA, CDE and other governments or departments effectively.5.Participate in all required internal and external trainings.Requirements:1.Bachelor or above degree in pharmacy or similar field.2.At least 4 year drug registration experience.3.Good understanding of local regulations, guidelines and requirements and have experience in preparation of submissions.4.Good English skills both in written and oral.5.Proficiency in Excel and other MS office tools.6.Good communication skills with cooperators and colleagues. 职能类别: 药品注册 关键字: 药品注册 硕士 英语

联系方式

北京市

公司信息

诺思格(北京)医药科技股份有限公司是国内专业领先,规模较大的临床研究合同组织(CRO)之一,总部设在北京,办事处设在上海、长沙、广州、武汉、成都、西安、哈尔滨、南京、沈阳、天津、长春、杭州等省会城市;在国内覆盖60余个城市,在亚洲覆盖6个国家与地区,已与200余家机构,450余家医院及600多个科室合作,目前已为260多位国内外客户提供国际标准的临床研究外包服务。业务涵盖新药评估与咨询、注册事务、临床试验实施、数据管理和统计分析、医学事务及培训等全方位服务。 “服务医药 服务健康”,详情请登录公司主页: www.rg-pharma.com 接收简历邮箱:hr@rg-pharma.com

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