Regulatory Affairs
hace 4 días
Empresa basada en la investigación con presencia global, centrada en el desarrollo y la distribución de medicamentos innovadores que mejoran la salud y el bienestar de los pacientes, busca incorporar un/a Regulatory Affairs para sus oficinas ubicadas en Madrid.
Su historia se extiende a más de 60 años y en España llevan más de 15 años comprometidos con los pacientes y con los profesionales sanitarios.
Principales Responsabilidades: Gestionar y coordinar todos los aspectos relacionados con los registros de productos nuevos y ya existentes ante las autoridades regulatorias locales.
Asegurar el cumplimiento de las normativas nacionales y de organismos como la EMA (Agencia Europea de Medicamentos) Elaborar y presentar dossiers regulatorios y proporcionar seguimiento a las evaluaciones y respuestas de las agencias reguladoras.
Mantener actualizada la documentación técnica y regulatoria, garantizando que se reflejen los cambios en las normativas y guías de buenas prácticas.
Requisitos: Formación académica: Licenciatura en Farmacia, Ciencias de la Salud, Química o áreas relacionadas.
Un máster o posgrado en Regulatory Affairs, Quality Management o Market Access será valorado.
Experiencia -Mínimo de 6 años en puestos similares dentro de la industria farmacéutica.
-Experiencia demostrable en la gestión de procesos regulatorios.
Se valora experiencia en calidad o acceso al mercado.
Conocimientos técnicos: -Profundo conocimiento de las normativas regulatorias nacionales e internacionales (EMA, FDA, etc.).
-Experiencia en la implementación y auditoría de sistemas de calidad (GMP, GDP).
Habilidades: -Capacidad de negociación y gestión de relaciones con autoridades sanitarias.
-Excelentes habilidades de comunicación, tanto oral como escrita.
-Fuerte orientación a resultados y habilidad para trabajar en equipos multifuncionales.
Competencias clave: -Pensamiento estratégico y capacidad para anticipar y adaptarse a cambios en el entorno regulatorio.
-Alta atención al detalle y habilidad para gestionar múltiples proyectos y plazos.
-Capacidad para liderar y coordinar equipos interdisciplinarios.
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