Time : Mon - Fri 08.00 - 17.00
- To process for all MOPH related Licenses in timely manner.
- To coordinate for the renewal and updating of Licenses.
- To process for product registration in timely manner.
- To ensure that technical specification and text amendments are updated in registration file.
- To review packaging artwork for text and regulatory compliance.
- To coordinate with authority for acquiring necessary permits.
- To coordinate with authority for purchasing of controlled substance.
- To coordinate with authority for witnessing the destruction of controlled substance.
- To review and submit the reports to Authority as required
- To coordinate with authority for the approval and inspection of plant design layout change/ or improvement.
- To prepare necessary technical file for Export or Import Registration.
- To arrange to have required Regulatory documents for Export or Import purpose.
- To organize the preparation of monthly / triannual / annual report to Authority.
- To organize the preparation of another report as regulation.
- To monitor monthly status report.
คุณสมบัติผู้สมัคร
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related field.
5+ years of experience in Regulatory Affairs within the pharmaceutical industry.
Strong knowledge of local and international drug regulations
Excellent communication skills to liaise with regulatory agencies and internal teams.
Strong analytical and problem-solving skills.
Proficiency in regulatory software and document management systems.