JOB DETAILS

JOB DETAIL

Products: Pharmaceutical Products

・Your main mission is to smoothly register new pharmaceutical products manufactured at company's Japanese headquarters with the Thai FDA.
・Currently, the Regulatory Affair Department at Japanese headquarters is in charge of FDA registration in Thailand, but company has decided to localize this work within Thailand.
・Preparation and submission of documents necessary for FDA registration
・Interview with FDA personnel and negotiations for smooth registration
・Coordination with the person in charge of the Regulatory Affair Department at the Japanese head office
・Cooperation with partner dealers in Thailand
・Other work assigned by the company

REQUIRED WORK EXPERIENCE

【Requirement】
・Must have experience as a regulatory affair executive at pharmaceutical company in Thailand for at least 8 years and must have experience in FDA Registration about pharmaceutical products
・Strong relationship with FDA
・Bachelor's degree in pharmaceutical major and must have pharmacist license
・Business level of English skill