Job Description
Regulatory Affairs Assistant (40K-60K) (SDG-22335) <Job Responsibilities> Ensure that a company's products comply with the regulations of the regions where they want to distribute them Keep up to date with national and international legislation, guidelines and customer practices Collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licenses and license renewals Prepare submissions of license variations and renewals to strict deadlines Monitor and set timelines for license variations and renewal approvals work with specialist computer software and resources Write clear, accessible product labels and patient information leaflets Plan and develop product trials and interpret trial data Provide strategic advice to senior management throughout the development of a new product Undertake and manage regulatory inspections review company practices and provide advice on changes to systems Liaise with, and make presentations to, regulatory authorities negotiate with regulatory authorities for marketing authorization specify storage, labeling and packaging requirements.
Job Requirement
<Necessary Skill / Experience > Thai nationality, male/female, 23-30 years Bachelor degree in Pharmaceutical or any related field Experience as Regulatory Affairs around 1 years Have pharmaceutical license Good command of English Computer literacy (MS Office etc.) <Preferable Skill / Experience> None Languages skills English: Conversational Level Japanese: None