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Sant Joan Despí

    senior regulatory affairs specialist - Sant Joan Despí, España - ARTHADA

    ARTHADA
    ARTHADA Sant Joan Despí, España

    hace 1 semana

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    De jornada completa
    Descripción

    ARTHADA, empresa líder en ofrecer servicios especializados de recursos humanos al sector farmacéutico, selecciona para un importante grupo Químico-Farmacéutico internacional en el área de los Genéricos un

    SENIOR REGULATORY AFFAIRS SPECIALIST

    Se responsabilizará de la elaboración de los expedientes de registro de especialidades farmacéuticas genéricas para aquellos países dónde la empresa o sus clientes deseen comercializar sus productos, principalmente entorno EMA y FDA. Mantendrá el contacto con los departamentos internos de la compañía y las empresas cliente. Asimismo, se ocupará de las variaciones y renovaciones. Responderá a las deficiency letters.

    • Licenciatura en Ciencias de la Vida.
    • Experiencia redactando dosieres de registros de productos farmacéuticos, principalmente módulo 3.
    • Experiencia en entorno EMA y/o FDA.
    • Capacidad de trabajo y dinamismo.
    • Dotes de planificación y organización.
    • Elevada capacidad de comunicación y trabajo en equipo.
    • Imprescindible inglés fluido.


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