• 3-4年经验
  • 硕士
  • 招1人
  • 11-09 发布

职位描述

职位描述: 职位描述:1、负责制订产品注册项目计划,实施并负责产品注册及咨询事务,包括新产品注册、已上市产品的资料变更等相关工作;2、审核药品注册申报资料,并保证在规定时间内完成申报;3、跟踪并促进所申报品种的审评及审批进程,及时解决或反馈该过程中出现的问题;4、及时捕捉并反馈、解读注册政策及产品申报信息,为公司决策提供建议。岗位要求:1、药学、生物化学及医学等相关专业硕士以上学历;2、在药品、生物制品等相关行业从事注册工作3年以上工作经验;3、熟悉国内外注册申报的法规和流程,熟悉欧美药品注册法规和相关指南;4、具有较强的药学及医学专业英语读写和专业词汇中英互译能力,具备较强的注册信息检索和分析调研能力;5、熟悉专利事务及相关工作,有多个项目的注册申报经验;6、熟悉药品研发过程,有调研立项、药品政府事务工作经验者优先;7、正直诚信,积极主动,责任心强,善于沟通,有较强的独立学习及工作能力;8、有欧美项目申报等相关工作经验者优先。 职能类别: 药品注册 医药技术研发人员 关键字: 技术法规 质量法规 药品注册 国际注册 FDA注册 法规事务

联系方式

广州市

公司信息

Andala Co. Ltd. is a well-known company with years of development in China. Its sales turnover and profit always rank at top in the Industry. Guangzhou Andala Co. Ltd. aims at providing the efficient solution for supply chain with business in technology, FMCG, retailing, fashion, medicine, automotive, chemicals, aviation Industry and other industrial sectors. Headquarter of Guangzhou Andala Co. Ltd. locates in Guangzhou with branches in Shanghai and Beijing. The Company is trying to provide the most efficient one-stop service for the customers. We are committed to become a first-class multinational group. Guangzhou Andala Co. Ltd. establishes a business network in many cities in China. With good reputation, Guangzhou Andala Co. Ltd. has been widely recognized and praised with its excellent service and continuously improved management systems. We will do all means to respect, take care of and motivate our staff to create an enjoyable environment. As our business is expanding quickly now, we sincerely invite competent and self-motivated individuals to join our team. We offer attractive remuneration package and career development opportunities to successful candidates. Candidates please send your applications with detail resume both in Chinese and English, recent photo, expected salary and contact number to our designated email address: hrjob@foxmail.com 有意者请将个人简历发至邮箱:hrjob@foxmail.com,谢谢合作!应聘资料将予保密。

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