RA Specialist

Description 1. 负责与注册团队一起制定项目注册策略; 识别注册风险，组织风险评估，制定解决方案。 Responsible for working with the registration team to formulate project registration strategy, identify registration risks, organize risk assessment and develop solutions. 2. 负责与注册团队一起制定并优化适用于一个中国研发的注册管理制度及流程。 Responsible for working with the registration team to formulate and optimize the registration management system and process applicable to a Chinese I&D. 3. 负责捕捉、反馈、更新、解读行业发展以及法律法规政策信息，建立公司产品注册相关技术信息库，协助完成新产品立项有关的调研、评估工作。 Responsible for capturing, feeding back, updating and interpreting the industry development, laws, regulations and policies, establishing the technical information database related to the company's product registration, and assisting in the investigation and evaluation related to the project establishment of new products. 4. 编制注册工作计划、总结；根据注册法规要求，参与所负责项目开发技术路线的制定、审核； Prepare the registration plan and summary; Participate in the define and review of the technical develop route for projects according to the regulations; 5. 撰写、整理申报材料（包括注册、变更注册、产品批准文号、新兽药监测报告等），提交申请并跟进审批进度，组织开展问题分析并制定最优解决方案 Write and submit dossier（including variation registration, product license application and new veterinary drug monitoring report.,etc） and follow up the approval progress, organize problem analysis and develop optimal solutions