Sridhar Nimmakayala

Background

About Sridhar Nimmakayala

I am a dedicated, self motivated person who enjoys team work and is interested in exploring different domains of the Pharmaceutical industry. Currently I am working with one of the largest pharmaceutical regulatory service provider in india. Being a part of the Regulatory affairs field, my professional experience includes complication of dossiers in eCTD and NeeS formats (both quality and clinical sections), filing variations and renewal of product license, handling charge controls and deviations from regulatory view, preparation of elemental impurity risk assessment reports per ICH Q3D guidelines, regulatory project management and forecasting of business requirements, Handling updates to core labels and local labeling, and HA requests. Published various research articles in the area of pharmacology and medicinal chemistry, having experience in successfully handling USFDA audits without 483 observations. Versatile regulatory experience covering CMC dossier compilation, compiling clinical parts of dossier, vendor management (including DMF, COE, COA procurement and review), lifecycle management of products, variations and deviation handling, regulatory project management and forecasting the requirements, regulatory submissions though RIMs, preparation of PDE and risk assessment reports, preparation of lables and handling labeling updates. Markets handled: EU, Australia, Newzealand, South africa, LATAM, ASEAN and other MOW countries.