Regulatory Affairs Manager/药品注册事务经理 广州

月薪： 2-2.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Regulatory Affairs Manager/药品注册事务经理 工作职责：1. 负责制订产品注册项目计划，负责组织实施产品注册及咨询事务；2. 负责管理公司药品注册文件，包括申报资料的填写、翻译和整理；保证在规定时间内完成申报；3. 跟踪项目研发及申报进度，协调解决委托研究、注册检验与申报等过程中碰到的问题，及时解决或反馈该过程中出现的问题；4. 掌握和跟踪国内外注册法规的变化，分析政策变化对公司带来的影响，并针对性地提出可行性解决方案；5. 负责药品注册申报、研制核查联系事宜；6. 跟踪并促进所申报品种的审评及审批进程；7. 开发和维护与相关政府部门及专家的关系；职位要求：1. 生物、药物、药品相关专业专业本科及以上学历，具备良好的专业背景；2. 5年的医药行业工作经验，具备丰富的药品研发注册经验，对国内和进口药品注册流程非常熟悉，对药品注册法规有比较深刻的理解，并能较好地指导药品研发工作，以保证药品研发工作的合规和顺利进行；3. 有良好的政府关系，能妥善处理政府质疑、政府公关；4. 有较好的沟通能力及团队合作精神；5. 性格开朗、积极乐观；6. 熟悉PPT、电子相册、电子杂志的制作。 职能类别： 药品注册 医药技术研发管理人员 关键字： 药品注册 注射剂注册 药品研发 技术法规 药品申报 新药研发 新药注册

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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