Charles Ahn

Office of Enforcement, Office of Regulatory Affairs, FDA, Whiteoak, MD  执行部，法规事务部FDA
Case Management Officer, 2004-2009, 2011- March 2012. 案件管理官员

China Office, Office of Commissioner, FDA 
Assistant Country Director, Shanghai, China, 2009-2011  中国办事处助理主任

I was the first hire of the agency’s working level International Office staff to be deployed outside the USA territory. In that position, I was involved in outreach, capacity-building, and education of the local government, pharmaceutical industry, and academia to increase the understanding of GMP’s, quality system, and the agency’s regulatory policies.  In addition, I was also performing inspections of the local pharmaceutical firms.  第一位受雇于FDA开展美国海外工作的国际办事处员工。在此期间，承担了对当地政府、制药行业、学术界的外延服务、能力建设和教育工作，提升他们对GMP、质量体系和FDA政策法规的理解。同时，也执行对当地制药公司的检查工作。

Office of Regional Operations, Office of Regulatory Affairs, FDA  地区运营部，法规事务部，FDA
Program Expert, Rockville, MD, 1996-2004  项目专家

I served as a program expert for inspections of pharmaceutical products at Division of Field Investigation (DFI). There, I supported the ORA’s field operations by facilitating guidance on inspectional and technical issues in pharmaceutical product area. Also, I frequently participated in inspections of complex manufacturing operations assisting field offices in evaluation of computerized/automated manufacturing processes.  作为DFI的项目专家执行对药剂制品的检查。通过指导药剂制品的检查和技术问题来支持ORA的外地业务。同时，也经常参与到对复杂生产操作的检查中去，协助外地部门评价计算机化/自动化生产程序

Office of Compliance, Center for Drug Evaluation and Research, FDA 
合规部，药物评价和研究中心
Compliance Officer, 1992-1996  监察主任

I served as a case reviewer for pharmaceutical CGMP issues in complex regulatory enforcement cases against pharmaceutical firms. Also, I was engaged in many of the Center policy issues ranging from API guidance, GMP regulations, process validation, electronic records and signatures, and a mutual recognition agreement effort with EU.  作为制药CGMP案列评审员，发布针对制药公司的复杂法规执行案例。同时，也从事很多中心的政策发布，涉及范围有API指导，GMP法规，工艺验证，电子记录和签名，与欧盟的互认协议等。

New York District Office, Office of Regulatory Affairs, FDA  纽约办公室，法规事务部，FDA
Investigator (Inspector), New York, NY 1986-1992  调查员，