Katerina Oikonomou
Regulatory Compliance Expert @GSK
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WORK HISTORY
Regulatory Compliance Expert @GSK
Parma, IT
Role & Responsibilities:NPI Compliance Lead for biopharmaceuticals and small molecules (including APIs).I manage CMC documentation (authoring, review and approval) and support GRA in meeting MSR requirements.Actively involved in inspection readiness activities (on-site audits and GMP desk reviews) as well as manufacturing site registrations and renewals.Key Achievements – 2025: Successful PAIs from AIFA, FDA, ANVISA and PMDA Marketing authorization approvals in EU, UK, CH, JP, BR, CA, US and RoW markets
EDUCATION
Università di Siena
Laurea magistrale LM in Farmacia, Pharmacy
Università degli Studi di Napoli Federico II
Esame di stato per abilitazione alla professione di Farmacista
ABOUT KATERINA OIKONOMOU
Regulatory Compliance Expert presso Gsk
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