cmcmanager

面议

市辖区

刷新时间：2023-03-06

职位描述

Job Description:

• Participate in establishing registration strategy for CMC activities. Update the checklist or technical requirements based on NMPA guidelines.
• Complete review CMC filing dossier separately to ensure the documents meet regulatory requirements and suggest the solution for the gaps in dossier preparation to HO R&D.
• Work with Regulatory PM to ensure the timely delivery of CMC submission documents.
• Coordinate the activities for dossier filing and CMC site audit etc.


Requirements:
1. PhD or Master in Chemistry, Pharmaceutical Sciences or related. Master with 6+ years of experience and PhD with 4+ years of experience in pharmaceutical industry, with hands-on knowledge of pharmaceutical development, such as Synthetic, Analytical, Pharmaceutical Preparation or Manufacturing (GMP) etc. CDE working experience as CMC reviewer is a plus.
2. Strong analytical skills in sorting information, formatting directions and problem solving. Great sense of logic thinking. Thorough knowledge of pharmaceutical industry regulations, and very familiar with NMPA guidelines
3. Good communication, learning and computer operation skills.
4. Good at English writing, reading and speaking.

其他要求

招聘人数：1人
职能类别：CMC

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。