注册总监

面议

上海市

刷新时间：2023-09-01

职位描述

    Job Responsibilities
  1 Provide input on regulatory filing strategies for program and study decision making;
  2. Plan and deliver regulatory activities in accordance of program/company goal；
  3. Prepare and validate registration dossier for IND, NDA, renewal and variation to ensure timely approval and fully meet authority regulations and guidelines;
  4. Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient way;
  5. Establish internal SOP and WI for regulatory affairs.
  
  Qualifications:
  1. Bachelor degree or above in life sciences, pharmacy, or medicine related majors;
  2. At least 7 years working experience in regulatory affairs for multi-national pharmaceutical companies or CRO；
  3. Solid regulatory project management skills；
  4.Good leadership and communication skills, ability to interact with different line functions, and to work with outside vendors and partner companies；
  5. Good command of English, both in written and spoken。  

其他要求

招聘人数：3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。