仕事概要
職種 | 専門職(コンサルタント、金融、不動産、専門サービス)/専門サービス(医療、福祉、教育、インストラクター) |
---|---|
業種 | その他/ |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
英語 (日常会話レベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 |
仕事詳細
Regulatory Affairs Assistant (30K-35K) (SDG-25451)
<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.
Workplace Area: BTS Pleonjit, Bangkok
Working Hour: 8:30-17:00 (Mon-Fri)
About the Benefits
Salary: 30,000–35,000THB
About the company
Products: Import & sell pharmaceutical products, and new drug registration, etc.
Business Type: Pharmaceuticals
<Necessary Skill / Experience >
Thai nationality, Male/Female, age 23-28 years old
Bachelor’s degree of 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
面接について
連絡先
Regulatory Affairs Assistant
RGFタレントソリューションズ株式会社
30000 〜 35000 THB