Dinesh Jadhav

About Dinesh Jadhav

MacLeods Pharmaceuticals relies on strong regulatory coordination to ensure compliance…

Experience

1. Jr Officer

   Macleods Pharmaceuticals Ltd

   Jul 2023 — Present · Mumbai, IN

   Compiled, reviewed, and submitted CTD (Module I to Module V), ACTD, and country-specific dossiers for LATAM, CIS, SEA, MENA, South Africa, and PIC/S regions (Canada, Australia)- Managed end-to-end submissions with minimal deficiencies and successfully led product reregistration and renewal processes across regulated and semi-regulated markets- Addressed complex regulatory queries with scientifically supported responses, ensuring first-time-right submissions and accelerated approvals- Executed post-approval changes, including variations (administrative & quality), product amendments, and lifecycle updates- Reviewed technical documentation such as STPs, COAs, FP Specs, BMRs, MMFs, and stability reports to ensure alignment with ICH, WHO, EMA, and Health Canada guidelines- Participated in OOS/OOT investigations and implemented CAPA plans, contributing to regulatory compliance and dossier quality- Coordinated with QA/QC for method validation, method equivalency studies, and alignment with pharmacopoeial standards (USP/BP/EP/IP)- Supported certificate management, including the legalization of COPPs, GMPs, manufacturing licenses, and inspection reports; managed apostillation and authority submission logistics- Conducted regulatory intelligence, literature search, and scientific referencing using PubMed, Google Scholar, and global pharmacopoeias for dossier justifications- Actively collaborated with cross-functional teams (RA, QA, QC, Production, F&D) to streamline submissions and ensure timely project execution.