药品注册专员/Regulatory Affairs/Regulatory Intelligence

该职位来源于猎聘 职责描述：

• Monitor and search National Medical Products Administration (NMPA) relevant laws, guidelines and other pieces of regulatory information (draft/in force) from Health Authority (HA) webpages and public databases, public conferences, workshops and associations activities;
• Prepare and issue weekly and monthly China regulatory and intelligence report (and alerts when necessary);
• Coordinate to collect and consolidate Novartis internal comments on draft legislation/guidance and submit the company position and comments to the HAs or associations before due dates, such as the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA);
• Monitor Center for Drug Evaluation (CDE) backlog solving progress and key projects moving speed in CDE to support Regulatory Affairs (RA) planning and strategy adjustment;
• Utilize external information from CDE website or provided by vendors about regulatory information (such as GBI, Insight), to support RA team to set up internal data base for well planning and communications.
• Coordinate other regulatory intelligence work assigned by Global Drug Development (GDD) China RA office and Head of China Policy.
• Coordinate internal regulation/guideline trainings to RA colleagues about emerging regulatory requirements by or cross functionally and via written communication, such as newsletters, information e-mails, etc. 任职要求： Education: BS degree or above on pharmaceutical, medical or Bio science Language: Fluency in English as a business language, good written English will be a plus Experience:
• Handled registration project and familiar with NMPA drug registration regulation and process
• Monitoring and search of relevant laws, guidelines and other pieces of regulatory information from Health Authority web-pages and public databases, public conferences,
• Having people net with RA of industry Personality: good at communication, open mind and team work spirit