Ynd716 | Regulatory Affairs Manager

hace 4 meses


Alcobendas, España Grupo Crit A tiempo completo

Proceso de selección continuo. FuncionesDesde Grupo Crit buscamos un/a responsable del departamento de Asuntos Regulatorios Europeos en relación con nuevos productos, nuevos registros, nuevos territorios y proyectos de BD para una empresa dedicada al suministro de productos farmacéuticos genéricos sobre todo para hospitales ubicada en Alcobendas.FUNCIONES: Será la persona responsable de la expansión en Europa en coordinación con las partes interesadas pertinentes, incluidos todos los centros de fabricación que producen para el laboratorio.Autorizaciones de comercialización en Europa.Coordinación de todas las actividades de registro relativas a nuevos productos / nuevos registros.Estrecha interacción y colaboración con los departamentos (internos y externos) implicados en la fabricación de nuevos productos: I+D, Producción, Garantía de Calidad, Control de Calidad, Sistemas de Calidad, Asuntos Técnicos, Validación, etc.Gestión y supervisión del trabajo del equipo y de los plazos correspondientes del proyecto. Planificación, seguimiento y revisión del trabajo realizado para cumplir los plazos establecidos.Llevará un equipo de 2 a 3 personas.SE OFRECE: Contrato indefinido.Horario: flexible.Salario acorde con la experiencia + beneficios sociales.Requisitos: Titulación universitaria.Experiencia laboral en Asuntos Regulatorios.Deseable: Máster en Farmacia. Se valorará estar en posesión de un título de postgrado en administración de empresas (MBA) o en Industria Farmacéutica.Experiencia laboral de al menos 5 años en Asuntos Regulatorios, proyectos y gestión de equipos.Dominio del inglés a nivel avanzado. Se requiere poder mantener una conversación fluida.Capacidad de organización, planificación y delegación.Capacidad para trabajar bajo presión y cumplir plazos.Buena capacidad analítica y de negociación.Capacidad para participar en reuniones de grupo y facilitarlas.#J-18808-Ljbffr


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