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Regulatory Affairs Manager

Company

Krka

Location

madrid, madrid

Posted

July 13, 2026

Position Overview

            
Maximice sus posibilidades de que su candidatura sea seleccionada asegurándose de que su CV y sus habilidades se ajustan al perfil.
Leading regulatory team of 2 Regulatory Associates
Management of registration procedures to obtain registrations for generic medicines in line with local legislation
Maintenance of existing registrations (variations, renewals), maintenance of regulatory data-bases
Translations of SPCs, leaflets and labelling from English to Spanish and vice versa
Reviewing approved product information in post-registration/production phase
Planning coordinating and supervising all activities needed for obtaining marketing authorizations
Communication with local authorities
Monitoring of local pharmaceutical legislation and monitoring the practice and trends of the Spanish medicine agency
Working closely with Regulatory affairs, Pharmacovigilance and QA hea...
        

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Regulatory Affairs Manager

Position Overview

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