My email contact is speedxquality@yahoo.comPROFESSION Summary- Strong Regulatory experience (More than 25 years) and Network in Asia- Founder of Asia Regulatory Professional Association- Author of Handbook of Medical Device Regulatory Affairs in Asia, 2nd editionOver 25 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products. Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party). Developed the First Asia Regulatory Affairs Certificate course since 2007 with over 3800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professional Associations) since 2010 with over 4600 members. Wrote the first Asia Regulatory Book, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now.Adjunct Lectureship & Visiting Professorship with Nanyang Technological University (Singapore), Tohoku University (Japan), Beijing University (China), Chinese University of Hong Kong (Hong Kong), University of Hong Kong (Hong Kong), Taipei Technical University (Taiwan), University of Sydney (Australia), Dongguk University (Korea)Specialties: bsi, budgeting, department of health, iso, iso 9000, japanese, leadership, management, mark, microsoft office, policy analysis, quality, reports, requirements, sales, sop, strategic,
Listed skills include Regulatory Affairs, Medical Devices, Pharmaceutical Industry, Fda, and 46 others.