Overview
Pharma RA officer 化药法规事务专员 Jobs in Beijing, Beijing, China at 诗华诺康科技发展(北京)有限公司
Title: Pharma RA officer 化药法规事务专员
Company: 诗华诺康科技发展(北京)有限公司
Location: Beijing, Beijing, China
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。