Esther Esteban

Background

About Esther Esteban

Project Lead of innovative products launches: Xerava and Giapreza. • Project lead of Promotional Material regulation. • Responsible person of Regulatory Strategies Portfolio - Line Extension products. • Lifecycle managment of Stablished Pharmaceutical Products (including biological products). Areas: pain, inflamation, digestive system, diabetes, oncology, CNS and vaccines; • Responsible of regulatory portfolio of Medical Devices and Food Supplements. • Previous experience in other therapeutical areas: neonathology and nefrology. • Types of registration procedures managed: Centralized, DCP, MRP and National. • Current activities: launches of innovative products, development of new regulatory strategies in multidisciplinar teams (marketing, medical department, planning and supply, finances, quality), supervision and coordination of the RA team and documentación of the different modules of the dossier: CMC, preclinal and clinical estudies; direct contact with the Spanish Authorities (AEMPS), submission of new dossiers and update of the approved. Update to the team of current legislation. Direct contact with the headquarters, Due Dilligence to other companies and Scientific Advice with the local authorities. • Experience with Branded products (prescription and OTC). • Price and Reimbursment procedures (core value dossier). • Other activities: revision of promotional materials (literatures, gimmicks, articles, etc) according to the Farmaindustria and ANEFP promotional codes, and local guidelines, Company VeevaVault PromoMats. • Personal skills: Good team leader making them feeling comfortable and leading them to reach objetives. Great capacity to motivate teams. Excellent managment on negociation with crossfuntional departments.