職位描述
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 focus2.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 versa3.Participate in project assessment and selection, product due diligence; analyze the product’s pharmacological data, safety data and clinical data4.Other work as assigned by the senior managementRequirements:1)Master or Ph.D. or MD degree in the relevant field of medicine or life sciences2)Strong R&D experience and regulatory affairs experience a plus3)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 plus5)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 writing7)Ability to recommend regulatory filing strategy and collaborate/ influence regulatory agencies8)Familiar with Dossier requirements and CTD format for China and global submissions9)Proactive, committed, reliable, a problem solver with sense of urgency and can-do attitude10)Must be a team-player; collaborate well with internal and external stakeholders.
