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 FDAWHO 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.
Job posted: 10.5.2020