进口药品注册专员 上海

月薪： 6-8千/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 11-15 发布
  • 五险一金
  • 补充医疗保险
  • 出国机会
  • 年终奖金
  • 定期体检
  • 节日生日福利

职位描述

职位描述： RA Specialist-Description of Job Duty:1.Responsible for collection of the required technical dossiers from India RA team for new IDL filing, IDL renewal filing, variation filing, and responses to CDE query, etc.2.Responsible for translation(English to Chinese), finalization and submission of the registration dossiers for new IDL filing, IDL renewal filing, variation filing, responses to CDE query and coastal testing, etc.3.Responsible for preparation of module 2 and overview information (dossier No.1-8）4.Responsible for communication with India RA team about current CFDA/CDE regulations and guidelines.5.Responsible for communication with the authorities including but not limit to CFDA, CDE, NIFDC, port IDC, etc, so as to smooth the registration/coastal testing progress.6.Finish the other RA relate进口药品注册专员，岗位职责：1.本科或本科以上药学相关专业毕业；具有良好的英语阅读和写作能力以及流利的口语。2.具有药品注册申报资料的实际翻译（英译中），整理和申报递交经验；3.具有2年或2年以上进口/国产仿制药的注册申报相关工作经验4.掌握CFDA关于药品注册申报资料的最新要求，熟悉药物主控文件的格式和内容；5.熟悉《药品注册管理办法》，掌握最新的药政法规和各项指导原则，熟悉进口/国产药品注册申报流程；6.具有与药品注册相关各法规部门沟通的能力；7.具有药品注册信息检索和分析调研能力有意者请将中英文简历以及期望薪金（税前）发至如下邮箱：1 tracy.xie83@aliyun.com2 xiazihua1984@126.com公司网址： www.sunpharma.com 职能类别： 药品注册 药品生产/质量管理 关键字： 药品注册 进口药品注册 药品注册专员 进口注册专员

联系方式

海市徐汇区中山西路1800号兆丰环球大厦

公司信息

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. Is and international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations and APIs as branded generic as well as generics in India, US and several other markets across the world. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. The company is pursuing NCE and NDDS programs with the aim to products based on proprietary technology to market. More information about the company can be found at www.sunpharma.com.

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