Regulatory affairs Professional with years of continuous advancement and expertise in Generic Drugs. Successfully filed 500+ variations and supplements across the globe. Expertises and knowledge in leading Regulatory operations and regulatory strategies, European Regulatory requirements and guidance. Expertises/Specialists: 1) Post approval maintenance activities for US (CBE, CBE-30 and annual reports) and EU (Type - IA, IB & II variations, PSUR and renewals) markets. 2) Initial application including administrative requirements. 3) Regulatory strategy for Eu submission. 4) Handling technical queries. 5) Dossier filing for Europe, Japan, AUS, US, Nz. 6) preparation of patient Information ( SmPC, PIL).