Prajakta Khadsare

-Led team of 7 members and managed performance reviews, resource allocation, and resource management. -Led global submission strategy planning and execution of CTA for interventional clinical trials [Initial CTAs, Amendments, IB submissions, CMC submissions, DSUR submissions, CTA submission via new CTIS portal, HAQs, CSR and End of trial notification] -Provided oversight on CRO deliverables and regulatory activities supporting CTA submissions.

Provide oversight on CRO activities including regulatory and study start up processes such as compilation of EUCTR submissions (review of Part I and Part II dossier) outsideVeeva. Review submission packages for EUCT Part I and Part II application form. Developed a country regulatory requirement tool to monitor regulatory trends and identify rate limiting steps in clinical trial applications. Conducted comprehensive analysis as part of the EU CTR Group to implement new EU CT regulation and CTIS process.