上海药明 IPO

上海 ·IT/互联网 ·1000-9999人

Specialist of Regulatory Affairs

13-25K·14薪

上海

5-10年

本科

全职

职位描述
Responsibilities:
The candidate will mainly provide regulatory support for assigned projects to ensure regulatory compliance and successful IND/NDA/BLA/MAA filings in China/US/EU/other countries or regions. The support includes but is not limited to:
1、Maintain up-to-date knowledge of biologic CMC relevant laws/regulations/guideline published by NMPA, FDA, EMA, ICH and other agencies or industry associations;
2、Lead/Assist the preparation of IND filing dossiers by working closely with technical functions to deliver CMC sections of IND package and supportive documents and ensure the quality and consistency of dossiers;
3、Provide regulatory guidance to the project CMC team during process development and manufacturing;
4、Communicate with clients about regulatory relevant issues.

Requirements:
1、Understanding of biologics development and/or manufacturing process, and NMPA/FDA/EMA requirements;
2、Working experience with regulatory affairs of biologics; registration/submission experiences with vaccine products are strongly preferred;
3、Working experiences with microbial fermentation and viral vector manufacturing, quality control or quality assurance relevant activities may also be considered;
4、Fluent spoken and written English;
5、Skillful at using Office software such as Word, Excel, Power Point and Outlook. Advanced excel macros and programming skills are pluses;
6、Good communication skills, positive attitude, multi-tasking skills, entrepreneurial and teamwork spirit;
7、Bachelor or M.S. degree and above in Pharmaceutical Science, Microbiology, Molecular Biology, Biotechnology, or Biochemistry; oversea study experiences are desirable; RAC certification is a plus;
8、3-5 year working experience with B.S. degree, or 2-3 year working experience with M.S. degree.
公司介绍
药明生物提供全面、综合及可高度订制的生物制剂发现,开发及生产服务。我们是全球领先的开放式生物制剂技术平台,提供端到端解决方案,让任何人能从概念到商业化生产过程中发现、开发及生产生物制剂。我们提供的单源式服务为客户节省了宝贵的项目时间和费用。
上海浦东新区上海药明生物技术有限公司富特中路299号
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