注册总监/注册经理

面议

市辖区本科及以上

刷新时间：2022-09-13

职位描述

Responsibilities:

 Strategically planning in IND filling, NDA strategy interacting with regulatory agents including FDA, EMA and CFDA;
 Supporting QA and Other Department for GMP auditing;
 Supporting CMC team for product development and manufacturing;
 Supporting clinical development in dealing with regulatory agents;


Minimum Requirements:
 Ph.D. from an accredited institute or equivalent training in related field with six (6) years’ experience OR Master Degree from an accredited institute with eight (8) years’ experience OR Bachelor degree with ten (10) years of technical experience in chemical disciplines within chemical research, analytical research, quality control, production formulation development or product development
 Record of accomplishment of regulatory approvals and demonstrated success in working with regulatory authorities
 Experienced in supporting in CMC staged and Clinical development in biopharmaceutical industry
 Exceptional analytical and problem solving skills; extensive medical, scientific and /or technical knowledge pertaining to pharmaceutical development or operations good judgment; exceptional interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting; effective communication skills; flexibility; self-confidence, achievement oriented with appropriate concern for quality are highly desirable soft skills
 Exceptional written and verbal communication skills including ability to acquire buy-inbehaviour from stakeholders (internal and external)
 Outstanding inter-personal skill

其他要求

招聘人数：1人
语言要求：英语
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。