根据国内外法规指南（尤其中美法规指南）相关要求，撰写或审核CTD资料
理解并应用法规指南，及其对注册申报和上市前及上市后的影响
策划、执行和管理注册申报事务，包括INDs、CTAs/IMPDs、NDAs和ANDAs
审阅技术报告，并参与项目申报策略讨论
协助BD、研发团队解决日常问题，并就注册法规事务提供建议
就可能针对无明确/具体法规指南的问题，提供注册建议并合理决策
与公司同事分享从项目中获得的知识经验
熟练运用eCTD尤佳
任职资格：
药学或其它生命科学学士学位本科以上学历（药理、毒理、临床、医学、公共卫生、合成、药物化学）
有3年以上注册法规工作经验者优先
注重细节且处事灵活，可有效处理紧急和大量工作
了解药品研发流程、注册申报和相关的国内外法规指南
熟悉现行法规指南要求以及CTD模块1、2、3、4和5内容
与全球药品监管机构沟通交流经验
良好的时间管理技能
熟练运用电脑、MS Word、Excel和PowerPoint
英语听说读写流利
Job Description
In this role you are responsible for prepare or review CTD dossiers according to current domestic and global regulatory requirements, specifically China and US markets
Understands and applies regulatory requirements and their impacts for submissions and pre- and post-market compliance
Plans, executes, and manages regulatory submissions including INDs, CTAs/IMPDs, NDAs and ANDAs
Provide inputs in technical reviews and strategic discussions on regulatory submissions
Support the BD, R&D teams to resolve daily regulatory queries and ability to advise and provide recommendations on regulatory matters
Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
Share knowledge and learnings gained from own projects with colleagues within and outside the department as appropriate
Familiar with eCTD is preferable
Qualifications
Bachelor's degree or above in pharmaceutical or other life science
A minimum of 3 years’ experience in regulatory affairs is preferable
Attention to detail and a flexible attitude enough to successfully handle conflicting time pressures and a large volume of work
Knowledge of drug development process, regulatory submissions and relevant domestic and global regulations and guidance
Understanding of current regulatory requirements and the contents of Modules 1, 2, 3, 4 and 5 of the CTD
History of successful interactions with global regulatory authorities
Good time management skills
Computer literate and advanced MS Word, Excel and PowerPoint
Fluent in English, written and spoken

其他信息
语言要求：英语
行业要求：全部行业