(CP)注册总监/副总监Director / Sr. Director – Regulatory Affairs

面议

市辖区

刷新时间：2020-10-28

职位描述

Company: Shanghai ChemPartner (ChemPartner)
Location: Shanghaizhangjiang, China 

Job functions: 

ChemPartner is a global full-service life science CRO/CDMO with over 18 years of pharmaceutical research experience.  With a team of more than 2000 experienced scientists, hundreds of western-trained pharmaceutical industry leaders, and seasoned pharmaceutical executive leadership at the helm, ChemPartner is aligned and dedicated to technically and strategically accomplishing the research, development, and manufacturing initiatives of pharmaceutical and biotech companies worldwide.

The person in this position will lead Regulatory Affairs group; his or her main responsibilities may include, not limited to:

·Lead and manage  group activities related to regulatory affairs within the corporation;

·Coordinate the efforts among different business units (BU) to complete IND and BLA submission in a timely manner;

·Provide guidance to BU heads on regulatory compliance;

·Provide complete regulatory submission package for integrated services inside and outside ChemPartner;

·Coordinate meetings and keep good communications with CDE officers;  

·Coordinate various research teams to address questions and requests from CDE or clients on IND and NDA/BLA submission;

·Manage multiple projects in parallel and set priorities within the group;

·Manage group members on a routine basis.

Requirements:

·Master’s or more advanced degree in pharmaceutical sciences, biochemistry, molecular biology, bioengineering, or other related life science fields;

·No less than 8 years of working experience in regulatory affairs, preferably representing multi-national pharmaceutical companies to file IND and NDA/BLA for molecule and large molecule therapeutics;

·Understands and be able to interpret regulatory policies set by NMPA, FDA and EMA;

·Knowledge and experience on pharmaceutical research, development and GMP manufacturing. 

·Excellent communication and management skills, plus a leadership vision; fluently speak and write in both English and Chinese.   

其他要求

招聘人数：1人
职能类别：注册总监

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。