Regulatory Affairs Officer (RA, JLPT N3 up)ID:42940
40,000 THB ~ 70,000 THBBTS (Sukhumvit Line)3ヶ月以上前概要
給与
40,000 THB ~ 70,000 THB
業界
Agriculture, Other
仕事内容
- Regulatory affairs officers ensure appropriate licensing, marketing and legal compliance of pharmaceutical and medical products, in order to control the safety and efficacy of products. (combining knowledge of science, law and business to ensure products that are developed, manufactured or distributed by a range of companies, meet the required legislation
- Ensure company's products are in compliance with MHRA regulations
- Keep up-to-date with international legislation, guidelines and customer practices in all countries
- Develop and write clear arguments and explanations for new product licences and licence renewals
- Prepare submissions of licence variations and renewals to strict deadlines
- Plan and develop product trials and interpreting trial data
- Advise scientists and manufacturers on regulatory requirements
- Provide strategic advice to senior management executives throughout the development of a new product
- Undertake and manage regulatory inspections
- Review company practices and provide advice on changes to systems
- Negotiate with regulatory authorities for marketing authorisation
求めている人材
応募条件
- Male or Female, Thai national, age between 28-45
- Having pharmacist license is a must
- At least 5 years experiences as Regulatory Affairs in related industry
- Has experience make ACTD documents
- Good command of English for business (Neo 3up)
- Considerable understanding of legal and scientific matters
- Good awareness of legislation governing the approval of products英語
Level 5 - Beginner Level
その他言語
English
その他
福利厚生
- Social Security Fund
- Medical Insurance
- BONUS
- Transportation Allowance就業時間
0900 ~ 1745
休日
- Weekends (Sat-Sun)
- Public Holidays (Thailand)
- Annual Leaves職種