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Oya Sevi Fırat
Regulatory Transversal Projects Coordinator - Gra International @Sanofi
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WORK HISTORY
Regulatory Transversal Projects Coordinator - Gra International @Sanofi
TR
EDUCATION
Orta Doğu Teknik Üniversitesi / Middle East Technical University
Chemical Engineering
ABOUT OYA SEVI FIRAT
With over 17 years of experience in regulatory affairs and regulatory compliance within the pharmaceutical industry, I am a seasoned professional adept at managing complex regulatory processes and leading cross-functional teams. I am experienced in pharmaceutical industry in CMC post-registration activities including; renewal, deficiency letter (DL) response preparation, manufacturing site transfers, COGs improvement, divestment projects and collaborative work with regulatory third parties for overseeing the quality aspects of regulatory submissions, ensuring adherence to company policies, and managing the effective implementation of new business models in emerging markets. I have good knowledge of pharmaceutical regulations and requirements, Health related regulations (i.e. ICH, EU, WHO, ANSM, MHRA, Emerging Markets, etc.)with hands-on knowledge with Vevaa, eDMS, InSight Publisher and validation tools. I am passionate about driving regulatory excellence and contributing to the advancement of pharmaceutical innovation through effective regulatory strategies and stakeholder engagement.
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