Regulatory Intern
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Job Summary
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12和3确保文件完整性及格式合规性
法规与文献检索跟踪NMPACDEICH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 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Intern
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
