Regulatory Affairs Executive

工作职责:

• 负责公司自营及客户委托的中成药 / 保健品产品注册与申报工作
• 准备、整理及维护产品注册所需的中英文资料文件
• 跟进注册进度,与相关监管机构进行沟通协调
• 协助内部及客户了解产品合规与注册流程
• 支持公司在产品合规及法规事务方面的日常工作

任职要求:

• 中药学、药学、药物科学、生物或相关专业背景
• 了解中药材、产品组成及基础制药知识即可
• 本岗位不涉及任何诊疗、开方或医师执业相关工作
• 具备良好的中英文读写与沟通能力
• 工作细心、有条理,具备良好的责任感与执行力
• 有相关注册或法规事务经验者优先(无经验可培训)

Key Responsibilities:

• Handle product registration and regulatory submissions for TCM health products and supplements
• Prepare, review, and maintain regulatory documentation in both English and Chinese
• Coordinate with relevant authorities and follow up on registration progress
• Support internal teams and clients on regulatory and compliance matters
• Assist in day-to-day regulatory affairs operations

Requirements:

• Background in Chinese Pharmacy, Pharmacy, Pharmaceutical Sciences, Life Sciences, or related disciplines
• Basic kn...