Regulatory Supervisor 注册主管 北京

月薪： 1-1.5万/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 员工旅游
  • 交通补贴
  • 年终奖金
  • 出国机会
  • 通讯补贴
  • 餐饮补贴
  • 定期体检

职位描述

职位描述： Position Summary?Participant in registration strategy discussion and responsible for implementation of the planned registration action?Compliance with applicable policies, procedures and other regulationsDuties and ResponsibilitiesI: Regulatory?Be fully responsible for the registration dossier preparation and submission of assigned projects;?Be responsible for timely order the registration sample, dossier, certificates…;?Contribute to the discussion of registration plan with both local and global team;?Achieve the target timeline of submission and approval;?Track the registration status in CDE and CFDA and timely report to the line manager;?Organize to answer technical questions referred by HAs;?Coordinate of F2F discussion meeting with HAs;?Communicate with HQ about the issues related to the responsible product registration; for example dealing with relative issues on drug quality test in HA’s lab;?Accountable for ensuring regulatory compliance for the responsible brands like License renewal, CMC, PI etc;?Monitor regulatory changes and report to line manager timely?Provide regulatory support for other functions (marketing, commercial, medical etc);?Ensure regulatory activities comply with Chiesi internal SOP for routine workII:Other tasks?Responsible for Quality Assurance (QA) activities in local level, including collect/archive the relevant of Manufacture/Quality information, and handle product issue & quality case in timely, and establish and maintenance of QA SOP. (if applicable)?Provide regulatory support for ongoing clinical trials, eg clinical trial registration, annual report etc (if applicable)?Fulfil other tasks assigned by the Line Manager.Qualifications (Knowledge, Ability, and Skill Requirements)?Bachelor or above degree in Life Sciences, Pharmacy or Medicine, or equivalent experience?Above 2 years working experience in regulatory affairs;?Familiar with drug production, chemistry and analysis;?Familiar with products registration approval application procedures and related regulations and laws;?Ability to read, analyze professional information and write professional articles;?Ability to solve problems independently;?Be good at communication, organization and coordination;?Good interpersonal skills and negotiation skills;?Fluency in spoken and written English.?Prior working experience in Health authority is preferred. 职能类别： 药品注册 药品生产/质量管理 关键字： 注册 医药 呼吸科

联系方式

北京

公司信息

凯西制药公司总部位于意大利帕尔马市，全球有超过4500名员工。公司业务覆盖全球市场，在全球25个国家建立了分公司并在很多地区拥有合作伙伴，2015年集团销售额已超14.6亿欧元。三个主要研发中心位于意大利、法国和美国，每年用于新药研发的费用为销售额的20％，有300多名员工专业从事研发工作。更多相关信息请访问凯西制药公司官方网站http://www.chiesigroup.com 或中文网站 http://www.chiesigroup.cn

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