CMC VP

面议

四川省硕士及以上

刷新时间：2020-10-12

职位描述

ESSENTIAL DUTIES AND RESPONSIBILITIES:
-        Define and execute the global CMC/quality regulatory strategy for Retrophin products including maintaining and extending product registrations in United States, European Union, Asia
-        Assure accurate and timely compilation and submission of regulatory documentation
-        Lead the Hinova Global CMC/Quality Regulatory function by providing direction, guidance, and mentorship to direct reports, and CMC colleagues
-        Direct and lead cross-functional submission teams to ensure creation and submission of global CMC/quality regulatory documents (NDA, MAA, Briefing documents, Variations, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
-        Manage CMC regulatory strategies and plans to ensure alignment with the overall project plan and business strategy
-        Contribute to quality related functions such as GMP requirements, draft and review SOP's, review quality and supplier agreements
-        Remain knowledgeable about current regulations and guidance, interpret and notify appropriate personnel of any changes, updates or revisions
-        As the global CMC/quality regulatory expert, ensure any necessary knowledge is transferred throughout the Regulatory team and internal stakeholders
-        Support new Business Development initiatives including due diligence and regulatory technical assessments as needed.
 
Qualifications
-        M.S. degree or Ph.D. Degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable
-        15+ years of experience in the pharmaceutical/biotech industry
-        8+ years of experience in pharmaceutical development of small molecules drug candidates
-        5+ years of experience in a regulatory leadership role
-        Authored CMC sections of regulatory filings for US, Europe, and Japan
-        Strong knowledge of current US and EU regulations and cGMPs, knowledge of Chinese regulations and cGMPs is a plus
-        S

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。