Regulatory Affairs Specialist

hace 2 meses


Barcelona, España Reig Jofre A tiempo completo

EnReig Jofreestamos buscando a un/aREGULATORY AFFAIRS SPECIALISTpara que pueda incorporarse al equipo de Regulatory Affairs en nuestras oficinas de Sant Joan Despí.Si te gustan los retos, te sientes cómodo/a en ambientes dinámicos y tienes vocación por la industria farmacéutica no dudes en seguir leyendoFunciones:Preparar y presentar el dosier de registro de medicamentos en Europa y en diversos mercados internacionales.Gestionar la correspondencia con agencias reguladoras y responder a consultas regulatorias.Mantenerse al día con los cambios en las normativas y evaluar su impacto en las estrategias regulatorias.Coordinar con los departamentos de I+D y producción para asegurar que los productos cumplan con todos los requisitos regulatorios.Crear y revisar los materiales de acondicionado y coordinar su implementación.Coordinar las diferentes actividades regulatorias con las filiales de la empresa.A ptitudes y experiencia requeridas:Licenciatura en Ciencias de la Salud.
Se valorará un máster o título especializado en Regulatory Affairs.Experiencia mínima de 3-5 años en un rol similar dentro de la industria farmacéutica.Conocimiento profundo de las regulaciones de la EMA, FDA y otras autoridades regulatorias internacionales.Experiencia en la preparación y gestión de documentación regulatoria.Habilidades en comunicación escrita y verbal, con capacidad para interpretar y explicar información técnica compleja.Capacidad para trabajar de manera autónoma y gestionar múltiples proyectos en un entorno dinámico.Nivel alto de inglés.Nosotros ofrecemos:Salario competitivo en función de la capacidad y experiencia del candidato.Horario flexible de entrada y salida (de 7:30h a 9.30h hasta las 16:30h a 18:30h)Contrato indefinido.Plan de compensación flexible (seguro médico, ticket transporte y restaurante, guardería, formación…).Formar parte de una empresa líder en el sector farmacéutico.Si cumples con los requisitos y quieres involucrarte en un nuevo reto profesional, no lo dudes Apúntate#J-18808-Ljbffr



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