JOB DETAILS

JOB DETAIL

- Prepare Pharmacopoeia Registration Documents: Compile and submit documents in accordance with the registration criteria for pharmacopoeia registration.
- Provide Medication Documentation: Prepare and review medication documentation, including labels, to ensure compliance with drug registration guidelines.
- Verify Drug Master File: Review and verify the Drug Master File to be used as supporting information for preparing the Qualify part document.
- Coordinate with Drug Division Staff: Collaborate and communicate with Drug Division staff regarding the submission of drug registration documents.
- Prepare Progress Reports: Compile and submit progress reports to the supervisor detailing the results of pharmacopoeia registration.
- Troubleshoot Issues: Effectively identify and resolve problems that arise in various situations, ensuring timely and efficient resolution

REQUIRED WORK EXPERIENCE

- Any gender (Thai nationnality)
- Age between 30- 45 years old
- Bachelor's or Master's degree in Pharmacy or related field.
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
- Experience in sterile pharmaceutical factory will be an advantage.
- Previous supervisory experience in a regulatory affairs role preferred