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
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其他要求
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1人
- 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。