Aishwarya Khabade

Regulatory Affairs Officer @Emcure Pharmaceuticals Limited

Pune, IN

Hands on experience on ANDA filing (solid oral and injectable), compilation, review and controls as per RTR guidance. Compilation for pre and post submission activities (CBE-30 (sp. site transfers), Gratuitous Amendment/ Amendments and Annual reports. Assisted in drafting controlled correspondence, responses and cover letters to FDA queries. Labeling US market - Drafted and Reviewed prescribing information, annotation comparison as per RLD for ANDA /NDA submissions. Carried out administrative activities specific to US Market (Establishment Registration, Drug Listing – DP as well as API). Prepared SPLs using Educe SPL software; ensured DailyMed drug product listing compliance. Contributed in Pre submission activities- TOC, Hyperlinking and SPT verification. Handling Regulatory tools – Educe, ESG NextGen, Dossier-Mgmt. Monitoring of US FDA websites like Drugs@FDA, Label search, DailyMed, Orange book etc. Handling agency’s communications – IRs, CRLs, DRLs. Effectively collaboration with cross functional department and ensure timely delivery of quality submissions.