温馨提示:一览严格审核企业资质,企业若在招聘过程中以任何名义收取求职者费用,均为违法行为,请及时向我们举报欺诈行为。感谢支持!×
专业要求:
学历要求:不限
工作经验:不限
薪资待遇:8001-10000 月薪
招聘人数:1
招聘对象: 社会人才
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 renewalsReview variation dossier to support filing strategy for CMC changesAssist HA CMC query process as necessaryMonitor the variation tracking sheetIdeal 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/biopharmaceuticals2.Good written/spoken communication and problem solving skills.3.Computer literacy.Jobsite: Zhangjiang Shanghai
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 renewalsReview variation dossier to support filing strategy for CMC changesAssist HA CMC query process as necessaryMonitor the variation tracking sheetIdeal 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/biopharmaceuticals2.Good written/spoken communication and problem solving skills.3.Computer literacy.Jobsite: Zhangjiang Shanghai
抱歉,您所选择的公司暂未填写公司简介!