Regulatory Intern

Description du poste:

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

支持罗氏中国技术注册部门工作，包括但不仅限于：

注册资料整理与汇编：协助收集，整理，校对药品注册申报资料（模块1，2和3），确保文件完整性及格式合规性。

法规与文献检索：跟踪NMPA，CDE，ICH等发布的最新药品法规，指南及技术指导原则，协助进行法规差距分析。

申报流程支持：配合完成电子递交（eCTD）的制作，盖章，归档等工作，协助处理补充资料（发补）的准备工作。

内部协调：协助与生产，质量等部门沟通，收集用于注册申报用途的技术支持性文件。

档案管理：协助项目负责人归档申报资料。

行政辅助：协助部门会议组织，会议纪要撰写，PPT制作等临时性工作。

任职资格：

教育程度
药学，制药工程，药事管理，化学，生物学等相关专业，本科及以上在读

岗位要求：
* 熟练使用Microsoft Office等办公软件，了解Google办公系列软件者优先
* 较强的英语听说读写能力
* 性格开朗，有亲和力，沟通能力与学习能力强，具备问题解决能力，对医药行业感兴趣者优先
* 了解项目管理工具/数据可视化工具/流程图制作工具者优先

出勤要求：
* 每周至少到岗2天

工作地点：
* 上海龙东大道1100号/北京市朝阳区金和东路20号院正大中心南塔

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer