职位描述
该职位还未进行加V认证,请仔细了解后再进行投递!
工作职责 1.Strategy: Form China development strategy map/decision tree for development portfolio including HA meeting strategy for pre IND, end of Phase II, pre NDA and DMF; NDA strategy including label, manufacturing source to optimize speed of approval, price and reimbursement negotiation etc. Form aligned China reflection paper to guide regulatory sub function s understanding and input to development and marketed portfolios to the new requirements trigged by the new and revised local technical guidance and regulations. Organize project deep drive at China RA department level to refine and align regulatory strategy for both development and marketed portfolio, ensure the execution of the defined strategy Ensure and provide optimal Regulatory strategy input for DD of in licensing activity in China 2.Compliance: To be responsible for 100% regulatory compliance to both health authority requirements and company internal policy. E.g. pre approval GCP and GMP inspection, annual report, promotional material LMR review, etc., 3.Efficiency excellence: As a backbone function for China RA, RCE focus on efficiency excellence to ensure maximize regulatory business outcome via exploring digital innovation tools. Focal point to provide comments and suggestions to global SOP and ensure its implementation in China RA. Creation, revision and retirement of local SOP for China RA and R
工作地点
地址:北京北京


职位发布者
拜耳HR
拜耳医药保健有限公司

-
石油·石化·化工
-
200-499人
-
外商独资·外企办事处
-
经济技术开发区
相似职位
-
产品专家(采购系统) 25000-45000元应届毕业生 本科网易(杭州)网络有限公司
-
蚂蚁集团-人力资源-ai产品专家 30000-50000元应届毕业生 本科蚂蚁科技集团股份有限公司
-
证券事务代表 面议应届毕业生 不限浙江正凯集团有限公司
-
淘宝天猫市场部-产品经理(天猫u先)-杭州 10000-20000元应届毕业生 本科阿里巴巴(中国)有限公司
-
淘宝天猫市场部-天猫品牌策略专家-杭州 25000-50000元应届毕业生 本科阿里巴巴(中国)有限公司
-
国际贸易事业部(icbu)-用增商务拓展-用户增长 10000-20000元应届毕业生 本科阿里巴巴(中国)有限公司