[C04] Regulatory Affairs Manager
hace 4 días
Proceso de selección continuo. Funciones
Desde 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.
- Contrato indefinido.
- Horario: flexible.
- Salario acorde con la experiencia + beneficios sociales.
- 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.
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