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Senior Manager/Director of Regulatory Affairs

hace 2 semanas


Barcelona, España Industria farmaceutica A tiempo completo

Desde Grafton Recruitment estamos colaborando con un importante laboratorio farmacéutico en la búsqueda de un Regulatory Affairs Manager para liderar las actividades regulatorias y garantizar el cumplimiento normativo en todas las operaciones. Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación. Responsabilidades principales Gestionar y coordinar los procesos regulatorios para productos farmacéuticos, asegurando el cumplimiento de la normativa local e internacional. Supervisar la preparación, revisión y presentación de dossiers ante autoridades sanitarias. Mantener actualizada la documentación regulatoria y dar soporte en auditorías e inspecciones. Colaborar estrechamente con áreas internas (Calidad, Producción, I+D) para garantizar la conformidad regulatoria. Monitorear cambios legislativos y evaluar su impacto en la compañía. Requisitos Titulación universitaria en Farmacia, Química, Biología o similar. Experiencia mínima de 5 años en asuntos regulatorios dentro del sector farmacéutico. Conocimiento sólido de normativas nacionales e internacionales (EMA, ICH, GMP). Inglés avanzado (oral y escrito). Habilidades de liderazgo, comunicación y gestión de equipos. Se ofrece Incorporación a un laboratorio líder en su sector. Proyecto estable y con oportunidades de desarrollo profesional. xsgfvud Paquete retributivo competitivo acorde a la experiencia.