Formulation Regulatory Affairs Executive/ Assistant Manager, Raniganj

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.