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职位名称:注册及申报资料监管总监 Director, Dossier/Regulatory Submission
公司行业:医药/保健/生物工程
最低学历:硕士 月薪:面议 最低工作年限:不限
招聘人数:若干 截止日期:2014-12-31 工作所在地:上海
    职位描述:
工作地点:中国上海外高桥保税区

To apply, please submit your CV and research summary to wang_siyuan@wuxiapptec.com

Key accountabilities:
1. Search and summarize pharmacological data, safety data and clinical data for drug or consumer products, with topical products and natural products as the focus
2. Independently prepare application documents for China filing in Chinese, and global filing in English including translation of pharmacological data, safety data and clinical data from English into Chinese, or vice versa
3. Participate in project assessment and selection, product due diligence; analyze the product’s pharmacological data, safety data and clinical data
4. Other work as assigned by the senior management

Requirements:
1. Master or Ph.D. or MD degree in the relevant field of medicine or life sciences
2. Strong R&D experience and regulatory affairs experience a plus
3. Broad industry knowledge, in-depth understanding of the mechanism of action of medicines, drug discovery and development, clinical development, and post-market drug performance monitoring.
4. Excellent written English and Chinese skills; familiar with literature searching both in Chinese and English; fluent oral English a plus
5. Ability to extract relevant data and perform in-depth analysis of the data 
6. Ability to clearly and concisely articulate the information verbally and in writing
7. Ability to recommend regulatory filing strategy and collaborate/ influence regulatory agencies
8. Familiar with Dossier requirements and CTD format for China and global submissions
9. Proactive, committed, reliable, a problem solver with sense of urgency and can-do attitude
10. Must be a team-player; collaborate well with internal and external stakeholders.
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