Regulatory Affair Officer

AA Medical

Established in 1996, AA Medical Products Ltd. has been making healthcare available across Myanmar for more than two decades. The company is delivering top medical healthcare products and services to millions of people every day. It has established a strong network across the country with 15 distribution facilities within all states and fleet of more than 150 vehicles. Its network servicing 19,000 hospitals, clinics, pharmacies and drug stores and allow AA Medical to reach every customers in every area of the country making AA Medical one of the largest pharmaceutical company in Myanmar.

We believe in making a difference in the communities we serve, not only improving healthcare, but also attributing communities & social welfare. We contributed cash, medicine, medical equipment, food, and other aids to different organizations. We are committed to supporting and implementing anti‐ malaria projects, with US based NGO (Population Service International), which are funded by the Bill and Melinda Gates Foundation and Department of Foreign Aids UK. With our extensive coverage of distribution network, malaria incidents significantly declined. We worked with UK registered charity focused of A4D NGO and providing the quality free glucometers, give educational talk, nutrition workshop to Type 1 Diabetes children.

We were committed to supporting the development of Nurses, Pharmacists and Medical Students in Myanmar and have launched a scholarship program for 20 nurses, 20 pharmacists, 20 medical students, for their university years. To update the latest medical technology and knowledge, we have donated various books to the Ministry of Health. To children and youths enduring obstacles as they grow up, we have donated 20,000 Chevrolet balls to help them cope with the challenges that they are overcoming.  We  have  also  donated  18  Chevrolet engines  and  nine  transmissions  to  Technical Universities Nationwide to help with improving experimental skills. To facilitate the time to reach a catastrophe that just occurred, we donated a Chevrolet car to the Red Cross.

In Addition, AA Medical Products Ltd. helps in the human resource development in public sectors; we have supported three medical doctors and one pharmacist to study at Chung Ang University (ROK). One scholarship to study a PhD degree and three scholarship to study a Master's Degree in pharmacology. Working together with Ministry of Health, Myanmar Maternal and Child Welfare Association   &  Myanmar   Women  Affairs Association,   we gave  Cervical   Cancer  Vaccines   to underprivileged teenagers. AA Medical Products
Ltd. organizes the Women's Health Education workshops and seminars to share knowledges in Anemia, Reproductive health, Personal Hygiene, and Skin Diseases in major cities.

Dagon Seikkan,  Yangon   19 February 2020
Job Reference: MJ1468982398381
Regulatory Affair Officer
  • Coordinate and interact with various internal departments for data collections required for dossier.
  • Review, check and collect data to be complied as per Pharmacopoeia, Specification, Batch manufacturing records, Stability, Finished
    product / Packaging material data etc.,                            
  • Compile data as per dossier requirement for the Myanmar FDA/WHO prequalification / ASEAN/ African/ CIS/ Gulf countries.                      
  • Maintain the regulatory update of CTD, ACTD & country specific regulatory guidelines, related IR application at DRI, MOI, MOHA                           
  • Create and prepare applications for Free Sales and COPP and obtain it as required time to time.                   
  • Prepare response to queries raised by Myanmar FDA as well as overseas regulatory authorities and get it reviewed with the RA Manager.                          
  • Prepare dossier timelines and closely follow the timely completion.                        
  • Prepare Standard Operating Procedures related to Regulatory Affairs department.                           
  • Prepare the documents for IR application (API, excipients, Reference standards, Chemicals) and get it reviewed with RA manager.                         
  • Whenever required coordinate with Myanmar Regulatory agencies (including FDA, DRI, MOI, MOHA of Myanmar).                     
  • Perform any other duties as assigned by the supervisor from time to time.


  • Bachelor’s Degree in science/Pharmacy/Pharmaceutical Sciences.
  • 3 Years’ experience in preparing dossiers for ASEAN/EU/TGA/FDA markets.
  • Experience Good Manufacturing Practices (cGMP)/Quality Management System (QMS) preferred.
  • Proficient in computer skills with Word/Excel/MS Office Suite. 
  • Good command in English & Myanmar language
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