Regulatory Affairs Team Manager at Kowa Korea Company, RAC
Industry
Medical / Health Care / Pharmaceuticals
About
An expert of regulatory affairs in pharmaceutical industry with more than 15 years of experience, and wide range of experience at the various organizations including Health Authorities (KFDA, MOHW), KPA (Korea Pharmacist Association), local pharmaceutical company (Yuhan Corporation) and multinational companies (BMS Korea, Korea Otsuka Pharmaceutical, Kowa Korea).
Regulatory Affairs Certified (RAC) by Regulatory Affairs Professional Society (RAPS) in 2014.
Specialties: Making new drug's development strategy, NDA process (Dossier preparation, submission, and approval of ETC & OTC drug and others), and IND process (multinational clinical trials IND dossier preparation, submission, and appr...
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