注册专员/助理RA Specialist/Assistant

Job responsibilities
1. Responsible for organizing the registration information of imported drugs, including translation, summarization, proofreading, submission, communication, etc;
2. Participate in the maintenance of registration information and data ledger management for listed products;
3. Participate in the evaluation and research of new products;
4. Participate in the management of drug surveillance for listed drugs, including information gathering, communication and coordination with third parties and headquarters, etc;
5. Assist in daily communication and exchange with overseas headquarters;
6. Complete other tasks assigned by superiors;
1、负责进口药品注册资料的整理，包括资料翻译、汇总、校对、提交、沟通等；
2、参与已上市产品的注册信息维护及数据台账管理；
3、参与新产品的评估和调研；
4、参与上市药品药物警戒管理，包括信息汇总，与第三方及总部的沟通协调等；
5、协助与境外总部的日常沟通及交流；
6、完成上级领导安排的其他工作；
Knowledge and Skills
1. Bachelor's degree or above in pharmacy or medical related majors;
2. Familiar with the technical requirements for drug registration, with at least 3-5 years of experience in drug registration work;
3. Familiar with the relevant functional departments and business processes of the Drug Administration;
4. Good English proficiency, proficient in oral communication, English writing and reading;
5. Experience in registering imported drugs is preferred;
1、药学或医学相关专业，本科以上学历；
2、熟悉药品注册技术要求，3-5年以上的药品注册工作经验；
3、熟悉药监局相关职能部门和业务流程；
4、英语良好，可以熟练运用口语交流，英语撰写及阅读；
5、有进口药品注册经验者优先；