Formulation Regulatory Affairs Executive/ Assistant Manager

Job description

Role & responsibilities • Keen Knowledge on Regulatory guidelines for finished product registration. • Dossier compilation as per guidelines. • Compilation and review the product dossiers for submission in CTD, ACTD. • Gap analysis of the dossier and addressing the gaps before submission to MOH. • Handling the customer and MOH queries. • Life cycle management of the product. • Development report, scale up report, specification, COA, stability protocol and Process validation protocol. • Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). • Post approval experience to file the applicable variations timely. • Knowledge on EAEU, ICH and EMEA guidelines. • Re-registration (Renewal) procedures. • Administrative documents requirements (COPP, Mfg. License and Import License) . • Registration information management system updates on regular basis.