Prajakta Khadsare
Angestellt, Regulatory Affairs Manager, Merck KGaA, Darmstadt, Germany
Frankfurt am Main, Deutschland
Werdegang
Berufserfahrung von Prajakta Khadsare
Bis heute 1 Jahr und 11 Monate, seit Juli 2022
Regulatory Affairs Manager
Merck KGaA, Darmstadt, Germany
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.
1 Jahr und 2 Monate, Juni 2021 - Juli 2022
Regulatory Submission Lead -CTA IND
GlaxoSmithKline GSK
Sprachen
Englisch
Fließend
Deutsch
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