RA Specialist

Description 1. Closely work with corporate and campuses, responsible for dossier analysis and preparing regulatory submission of import product, renewal, variations registration. 与公司总部及生产厂紧密联系，负责进口产品的文件分析、注册、再注册、变更注册文件的准备和提交。 2. Follow-up the registration progress, conduct regulatory activities according to the need of authority and intercompany (including response to queries, samples import clearance, quality compliance test, labeling etc.). 跟踪注册进度，根据官方及公司内部需要实施注册活动（包括问题回复、样品清关、质量复核试验、标签确认等）。 3. Maintain good contact with officials, CROs and other partners. 与政府、试验机构及其他合作伙伴等维持良好联系。 4. Keep update on changing regulatory requirements and knowledge, identify and report their related impact on company. 更新注册法规及相关知识，识别并报告其对公司的有关影响。及时更新注册政策的变化，并向公司汇报可能的影响。