高级注册经理 北京

月薪：

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： ? Establish, maintain and develop good relationships with the State Drug Administration (SDA), to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).? Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and GSK requirements.? Ensure that GSK Bio. Regulatory Affairs are kept fully informed on the current regulatory status of all assigned products.? Ensure that Import product labeling and PI is consistent with SDA guidelines and requirements.? Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to SFDA.? Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with SFDA and GSK requirements.? Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.? As required co-ordinate activities with GSK Bio RA.? Assist the Manager in supporting and providing a service to other functions and departments (e.g. Clinical and Marketing).5. When the job holder becomes the member of QMS Implementation Team, she/he is responsible for her/his assigned supporting work.Preferred qualifications:1. Preparing and submitting the documentation for new registrations and renewal of existing regulatory approvals for finished product imports. Current scope includes:? Import :? Current products IDL renewal and its variation? New products registration? Localization: Repackaging license and its renewal2. Commercial supplying: to trace all commercial goods CoAs from NICPBP3. Cooperate with GSKBS GMP certificate4. Regulatory Affairs:? Regulation search and distribute to relevant parties internally? Involve in regulation influence activities? Involve in related industry regulatory activities 职能类别： 药品注册

联系方式

北京市区

公司信息

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