Pharmacist (Regulatory affair)

Location Bangkok
Discipline Health Care & Life Science
Job reference BBBH45807_1708587900
Salary THB25000.00 - THB40000.00 per month
Job startdate ASAP
Consultant email [email protected]

Job Description:
- Follow the latest announcements and regulations of the Ministry and relevant external agencies.
- Collect and prepare documents for registration of new drugs according to ACTD criteria or others that the FDA announces and process the documents to follow up on progress until completed.
- Collect and prepare documents to amend the recipe registration according to the announcement or when there is a change in the drug registration and filing of documents Follow the progress until completion.
- Take various actions Regarding various factory licenses such as amendments, renewals.
- Contact the Department of Medical Sciences to purchase standard substances and germs used in the laboratory.
- Check various documents used in the factory to match the information in the recipe register and coordinate with relevant departments.
- Attend the TPMA Registration Subcommittee meeting every month.
- Coordinate between the factory and outside agencies.
- Process documents within the factory in accordance with procedures in the document system.
- Check compliance with relevant requirements according to GDP principles.

- Bachelor of Pharmacy.
- Be responsible Able to plan and follow the plan until it is successful.
- Have knowledge and understanding of quality systems (GMP PICs, GDP)
- Able to use a computer well, only Microsoft Word, Excel.
- Have communication skills and coordinate well with others.