美国当地临床和RA职位（新泽西，费城和波士顿）

公司简介：

以全球生命科学大使为己任，通过内部研发和外部合作提供多源的医疗平台

一家专注于临床新药开发的创新生物制药公司。立足中国和亚太地区，通过从早期到后期的临床在研产品的开发和引进全球已上市的成熟产品，将最尖端的创新疗法带给患者。团队在亚太具有丰富的临床研发，新药监管以及市场经验，并将与世界各地学术科研机构以及领先生物制药企业在亚太国家及地区具有高发病率和迫切研究需求的疾病领域展开合作。

公司已完成过亿美元的B轮融资

职位需求：

1）Regulatory Affairs：ONE RA manager/Senior Manager（up to D-level）

2）Clinical Operations：ONE Clinical Operation Manager/Senior Manager

3）Clinical Development：ONE to TWO Medical Director/Physicians

4）*Others：ONE PM

• Based in Philedelphia or Boston

• Shuttle between SH and EST

基本要求：硕士及以上学历，3年以上相应的工作经验

薪资福利：美国当地的水平

另外新泽西地区需要俩个生物药领域的RA, 一个负责临床领域，一个负责CMC领域

TITLE: Director/AD, CMC Biologics Regulatory Affairs

The responsibilities include working closely with functional areas and project teams to support regulatory chemistry and manufacturing control (CMC) execution as it pertains to the biosimilar/biologics programs that Global Regulatory Affairs supports.  The basic role is to provide CMC biologics and regulatory guidance to the project teams, lead the development and implementation of global CMC regulatory strategy for biosimilar/biologics, provide CMC regulatory support for the new and ongoing clinical trials, prepare the CMC part of the IND/BLA filing and response to HA questions related quality, and support all CMC biologics regulatory activities. The individual must possess a thorough knowledge of global regulation and guidance governing biosimilar/biologics in all phases of development. Strong communication and management skills are required.

往期文章：

我的目标

1）海外生物医药人才的寻访

2）海外生物医药项目融资和引进

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