Pharma RA officer 化药法规事务专员

该职位来源于猎聘 职责描述：

• 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。
• 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）。
• 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。
• 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。 任职要求：
• Bachelor or above degree in veterinary or pharmaceutical related course. 本科及以上学历，兽医或医药教育背景。
• Minimum 3 year experience in veterinary pharmaceutical product registration. 至少3年以上兽药注册经验。
• Good English skills both in written and spoken. 英文流利。
• Good interpersonal communication skills. 良好的人际沟通能力。
• Assist to perform other RA related task. 协助其他注册相关工作。