杨青青's Location
Chongqing, China, China
About 杨青青
药学研发背景&化药注册经验涵盖全生命周期
杨青青 Work Experience Details
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注册经理杭州泰格医药科技股份有限公司 Mar 2020 - Present中国 北京作为PM,独立承担的项目:2个进口IND(化药1类,化药2.2&2.4类)申请,已顺利获批;1个国产化药3类ANDA申请(资料撰写至受理),目前正在审评中;1个进口NDA申请(5.1类),目前审评中;多个NDA申请(5.1类&5.2类,Co-PM)5个进口原料药备案,其中1个已获A状态,2个正在发补审评,1个首轮审评,1个资料准备阶段;1个进口一致性评价申请,目前处于发补审评;1个进口再注册,已经顺利获批;2个精麻立项,1个已经申报,1个资料准备;2个pre-IND&1个pre-ANDA meeting其他:多个进口辅料包材备案 -
注册主管重庆药友制药有限责任公司 Oct 2018 - Mar 2020中国 北京市1.5年注册经验:作为注册主管,负责公司内部200余个产品再注册,数10个产品上市后变更,以及日常研发项目咨询;协助完成1个化药1类NDA申报,2个化药4类申报,3次现场质量审计,多个缺陷分析、技术咨询等工作 -
研发/药学/分析研究员重庆药友制药有限责任公司 Aug 2015 - Oct 2018中国 重庆市3年实验室研发分析经验:做为项目负责人,完成2个一致性评价项目的立项、拆方、申报资料撰写,发补回复、现场核查,直至获批;
Frequently Asked Questions about 杨青青
What company does 杨青青 work for?
杨青青 works for 杭州泰格医药科技股份有限公司
What is 杨青青's role at the current company?
杨青青's current role is 杭州泰格医药科技股份有限公司 - 注册经理.
What schools did 杨青青 attend?
杨青青 attended 中国药科大学.
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