Regulatory Affairs Specialist 注册专员
职位描述
Position: Specialist of Regulatory AffairsLocation: Beijing/Shanghai, ChinaReport to: Manager of Regulatory AffairsKey Responsibilities: ?Compile registration dossier and ensure timely regulatory submission of import drug application or local manufacturing application. ?Keep tracking the project registration process and resolve any issue timely to ensure earliest possible registration.?Communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing. ?Continuously monitor the new regulations and policies of healthcare and pharmaceutical products, and ensure the potential impact to projects or company business have been thoroughly evaluated and well communicated.Qualification: ?Medical/pharmacy/life sciences background, B.S. or above?Over 2 years regulatory experience in a globe leading pharmaceutical company or CROs?Be familiar with regulations and guidelines in CFDA, FDA and EU?Excellent communication skills and convincing skills in both Chinese and English?Good team player?Open attitude, Willing to meet challengesQualified candidates are welcomed to send your CV to hr@wuxipra.com .
企业简介
十一年前,药明康德的创始人李革博士肩负着变革新药研发、造福人类健康的人生理想,创立了药明康德;如今,药明康德已成为在中美两国拥有7000余名员工、中国首屈一指、全球领先的医药研发外包服务供应商,在全球九大城市拥有运营实体,客户囊括全球制药巨头前二十。作为国内医药研发服务的领头羊,药明康德无疑是卓越的医药研发平台,并继续致力于打造创新型的、全方位一体化的研发服务平台。
[展开全文] [收缩全文]上海相关职位: 销售三部总监/副总监(医保/自费药招商)
热门区域招聘: 重庆 北京 上海 浙江 江苏 广东 山东 湖南 安徽 河北
上海招聘企业: 上海信谊药厂有限公司 上海强生制药 欧姆龙健康医疗(中国)有限公司 青海瑞成药业(集团)有限公司 上海交通大学医学院附属瑞金医院 复旦大学附属中山医院 上海复星医药 上海医药集团 上海脉启科技有限公司 上海现代哈森(商丘)药业有限公司
职位发布日期: 2015-01-21