Regulatory Affairs(Senior Level)ID:53058
40,000 THB ~ 80,000 THBBTS (Silom Line), MRT LineOver 3 months agoOverview
Salary
40,000 THB ~ 80,000 THB
Industry
Manufacturing(Cosmetics/Healthcare), Manufacturing(Pharmaceutical/Medical Equipment)
Job Description
-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.
Qualifications
Requirement
-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 speakingEnglish Level
Level 3 - Business Level
Other Language
English
Additional Information
Benefit
- Position Allowance
- Transportation
- BONUS
- Insurance
- Provident FundWorking Hour
08:30 ~ 17:30
Holiday
- Weekends (Sat-Sun)
- Public Holidays (Thailand)Job Function