职位详情

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 ****ing 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 / ****ing of chemical drug/biopharmaceuticals2.Good written/spoken communication and problem solving skills.3.Computer literacy.Jobsite：Zhangjiang Shanghai