Regulatory Affairs ManagerID:47072
80,000 THB ~ 90,000 THBBTS (Silom Line), BTS (Sukhumvit Line), MRT Line, Rama III, Ratchadapisek - Phetchaburi, Changwattana - Ngam Wong Wan, Lat Phrao, Din Daeng/Vibhavadi/Don Muang, Rama II, Phra Pradaeng - Suksawat, King Kaew- Suvarnabhumi , Latkrabang, Srinakarin - Pattanakarn - Pravet, Bangna, All Airport Link Lines, Ramkhamhaeng/Bangkapi/Bueng Kum, Talingchan-Pinklao, Phutthamonthon - Nakhon Pathom, Samutprakarn, PathumthaniOver 3 months agoOverview
Salary
80,000 THB ~ 90,000 THB
Industry
Manufacturing(Cosmetics/Healthcare), Manufacturing(Pharmaceutical/Medical Equipment)
Job Description
- Complete all documentation tasks for drug, medical devices and cosmetics to be filed and registered mainly at Thai FDA and Myanmar FDA
- Complete all documentation tasks for variation application to the amendment of commercial products
- Complete all documentation tasks for GMP clearance process
- Candidates should be able to communicate in English with international colleagues to exchange information regarding regulatory affairs
- Candidates should be able to review and identify impacts from new regulatory guidelines and regulatory trends, monitor changes in regulations, and consider all proper measures needed to complete tasks
Qualifications
Requirement
- Male or Female, Thai nationality, age between 30-40
- Bachelor's Degree in Pharmacy
- Work experience, minimum 7 years, in Thai regulatory affairs and drug ACTD documentation
- Good knowledge of local regulations for the registrations of drug, medical device, and cosmetics
- Good interpersonal skills (to manage work with colleagues, agencies, and regulatory bodies)
- Good command of written and spoken English
- Confident to respond to rapidly-changing situations
- Ability to take appropriate actions independently
- Highly-motivated and enthusiastic attitudesEnglish Level
Level 5 - Beginner Level
Other Language
English
Additional Information
Benefit
- Travel Allowance (10000 THB)
- Pharmacist License (10000 THB)
- OthersWorking Hour
8.30 ~ 17.30
Holiday
- Weekends (Sat-Sun)
- Public Holidays (Thailand)Job Function