南平招聘

职位描述：
Job Purpose
Responsible for supporting the preliminary documentation for regulatory submissions concerning the CMC parts of CTA, NDA, license renewal and post approval change according to the agreed timelines.
Major Activities
1.Provide high quality documentation and business support for development projects.
Support the preparation of local specific documents according to the global CMC dossier.
Support to the preparations of CMC change summary, risk assessment and other documents.
Provide support to the HA lab testing if issues arise.
Provide support to other RegCMC business as needed.
2.Provide high quality and business support for marketed products.
Perform preliminary gap assessment to support license renewals
Review variation dossier to support filing strategy for CMC changes
Assist HA CMC query process as necessary
Monitor the variation tracking sheet
Ideal Background
Education ： (minimum/desirable):
BS in Chemistry, Biology, Pharmacy, Biochemistry.
Languages:
Fluent English and Chinese
Experience/Professional requirement:
1.3-5 years in RA/CMC preferred, and/or technical experiences in manufacturing / testing of chemical drug/biopharmaceuticals
2.Good written/spoken communication and problem solving skills.
3.Computer literacy.
Jobsite： Zhangjiang Shanghai 举报 分享

       FESCO，中国人力资源行业创始者，中国500强企业。为全球在华万余客户提供全方位人力资源解决方案,包括人事福利外包、招聘测评、外籍人服务、专业外包、专业咨询等。
    北京外企服务集团有限责任公司（FESCO）成立于1979年，是我国人力资源服务行业具有开创意义的***家企业。经过近40年发展，外企集团已经发展成为一个以人力资源外包服务为主，涉及旅游会展、文化传媒、房地产物业等相关领域的企业集团。