【Closed】Regulatory Affairs Assistant

Job Detail

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.




<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