Regulatory Affairs(Senior Level)ID:53058
40,000 THB ~ 80,000 THBBTS (Silom Line), MRT Line3ヶ月以上前概要
給与
40,000 THB ~ 80,000 THB
業界
Manufacturing(Cosmetics/Healthcare), Manufacturing(Pharmaceutical/Medical Equipment)
仕事内容
-Preparing registration dossiers according to local regulations and FDA requirements.
-Providing support in relation to permits, licenses, approvals and all registrations, including FDA, BOI, OAE and DIW and applying and reviewing the relevant permits/licenses as required by law/regulations.
-Managing Thai FDA comments during the submission process and ensuring that products will obtain registration approval within related timelines.
-Filing documents for variation amendments.
-Ensuring that all key products will be submitted following the strategic plan.
-Liaising with the regulatory authorities to obtain registration certificate approval or amendment approval.
-Ensuring that products comply with the current laws and regulations.
-Providing support in terms of product importation by ensuring that all documents are aligned with local requirements.
-Arranging and updating packaging artwork of registered products.
-Performing various other tasks as assigned by supervisors.
求めている人材
応募条件
-Male or Female,Thai national,Age 27-40 years old
-Bachelor’s Degree in Pharmaceutical Sciences
-At least 5 years of experience in regulatory affairs
-Have Pharmaceutical license(Preferable)
-Good command of English, both writing and speaking英語
Level 3 - Business Level
その他言語
English
その他
福利厚生
- Position Allowance
- Transportation
- BONUS
- Insurance
- Provident Fund就業時間
08:30 ~ 17:30
休日
- Weekends (Sat-Sun)
- Public Holidays (Thailand)職種