-Team working in analyzing the tablets and capsules based on quality-related parameters.
-Team working in preparing the required documentation for submitting the pharmaceutical dossier into the ministry of health includes CTDs, SOPs, reports.
-Create and manage effective communication and close collaboration with MOH, Keeping up-to-date with the latest news in MOH and pharmaceutical industry.
-Follow up all affairs of technical department, provide reporting on a regular basis to executive management to ensure timely execution of regulatory strategies to support launch activities and compliance status for maintenance projects and activities.
-Routine maintenance of regulatory files international regulation, guidance and standards applicable to company products.
Requirements
-B.Sc or M.Sc
-At least 2 years of experience in the regulatory field and pharmaceutical company.
-Strong communication skills and presentation skills
-Familiar with TTAC website, registration of drugs, supplement and APIs & getting IRC in MOH
-Energetic, self-motivated with a good team work spirit
-English proficiency in all skills
-Teamwork ability