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Regulatory Affairs Manager
hace 4 semanas
Importante Laboratorio Farmacéutico de genéricos y biosimilares dentro de los Top 10 en su país; en pleno proceso de crecimiento y expansión en Europa precisa incorporar a un/a Regulatory Affairs Manager para su HQ Europeo en Madrid.
En dependencia de la Dirección del Área se encargará principalmente de garantizar que los productos de la compañía cumplan con todas las regulaciones y normativas aplicables.
Principales funciones:
Interpretar y mantenerse actualizado sobre las regulaciones locales, regionales e internacionales que afectan a la industria farmacéutica.
Desarrollar estrategias para garantizar el cumplimiento regulatorio en todas las etapas del ciclo de vida del producto.
Coordinar y preparar la documentación técnica y científica requerida por las agencias reguladoras para la aprobación de productos.
Evaluar el impacto de los cambios regulatorios y desarrollar planes de acción para su cumplimiento.
Garantizar que la empresa opere de acuerdo con los estándares éticos y de cumplimiento.
Se requiere:
Un/a profesional con alta capacidad de autonomía e independencia, proactividad, organización y capacidad de priorización. Resolutivo, con habilidades comunicativas y relacionales.
Imprescindible formación universitaria en Ciencias de la Salud o similar.
Imprescindible experiencia previa como Regulatory Affairs o posición similar. Valorable experiencia como Regulatory Affairs a nivel internacional.
Alto nivel de inglés.
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