Nedumathi Thiyagarajan

Senior Scientist - Regulatory Affairs CMC @ MSD

About

M.Pharma in Pharmaceutics with 12 yrs experience in Drug Regulatory Affairs for filing the Biologicals/Biopharmaceutical/Biosimilar product, Prescription and Generic (P&G), Over the Counter (OTC), Consumer drug product dossiers with various international health authorities for obtaining registration/approval/renewal. Handling a team for the productive, quality work which helps the company business. Working for emerging market (ASIA, ASEAN, SAARC, LATAM, ME, CIS, and AFRICA) for filing the product dossiers since 2006. Specialized in dossier compilation (CTD, ASEANCTD, ZACTD)/review/tender application/technology transfer/Due diligence/customer audit/ customer support/health authority inspection/query response/deficiency response/labels review/team management/Liaison with CFT/archival system/communication/documentation. Experience in Bio-similar/Standalone requirement of the regions. 2 yrs worked in Production line and Quality control (2002-2004)

Country

india

City

bengaluru

Industry

pharmaceuticals

Skill

cross functional coordination, drug product, artwork reviews, gmp, regulatory affairs, validation, regulatory requirements, technical documentation, country specific guidelines, emerging markets, pharmaceutics, regulatory submissions, ctd, anda, actd, quality reviews, pharmaceutical industry, technology transfer, glp, dossier preparation, sop, track record, tender submissions