Regulatory Affairs Specialist 法规事务专员

1. Closely work with corporate and different campuses, responsible for dossier analysis and preparing regulatory submission of import product, renewal, variations registration.

与公司总部及不同生产厂紧密联系，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, GMO application, labeling etc.), and keep maintenance of the portfolio.

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、GMO申请、标签确认等）， 并负责所有的生物制品产品维护。

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.

不断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。

5. Assist to perform other RA related task.
协助其他注册相关工作。

Job Requirements
岗位要求

1. Bachelor or above degree in biological, veterinary, or in life science related course.

本科及以上学历，生物制品、兽医或生命科学教育背景。

2. Minimum 3 year experience in biological product registration.

至少3年以上生物制品注册经验。

3. Good English skills both in written and spoken.

英文流利。

4. Good interpersonal communication skills.

良好的人际沟通能力。

职位福利：五险一金、带薪年假、补充医疗保险、定期体检、周末双休、交通补助、采暖补贴