<ul><li>Review and compile resitration dossiers for ASEAN, CIS and ROW countries (Latin America, CIS Countries, Africa, South East Asia Pacific).</li><li>Knowledge of MFR, PDR, BMR, PVR, Specification, Analytical Methods, COA, Analytical methods validation report, API specification, RM Specifications, Finished Product Specification, Stability Protocols, Stability data.</li><li>Knowledge of Technical documents Like Drug Master File, COAs, Stability Data and follow ups with the government department.</li><li>Preparation of various pharmacological, pre-clinical &amp; toxicological data BTIF, RMP, PSUR, SPC, Packing insert &amp; Patient Information Leaflet.</li></ul>

Drug Regulatory Affairs-Asst. Manager/Dy. Manager/Manager