Regulatory Affairs Specialist
Completa
Hays
Descripción de la posición
Buscamos un/a Regulatory Affairs Specialist para incorporarse al equipo y dar soporte en la gestión regulatoria de productos, asegurando el cumplimiento de la normativa vigente a nivel nacional e internacional.
La persona seleccionada participará en actividades clave de registro y mantenimiento regulatorio, colaborando con equipos multidisciplinares.
Funciones principales
- Preparación, revisión y presentación de dossiers regulatorios
- Gestión de registros de productos ante autoridades competentes
- Coordinación de variaciones, renovaciones y lifecycle management
- Garantizar el cumplimiento normativo aplicable
- Revisión de documentación técnica, etiquetado y claims
- Interacción con autoridades regulatorias cuando sea necesario
- Colaboración con departamentos internos (calidad, supply, laboratorio, etc.)
Requisitos
- Formación en Farmacia, Química, Biología o similar
- Experiencia previa en Regulatory Affairs (ideal ≥2 años)
- Conocimiento de normativa aplicable (EU/MDR/EMA/AEMPS según aplique)
- Experiencia en registros y mantenimiento regulatorio
- Nivel alto de inglés (mínimo B2-C1)
- Perfil organizado, analítico y con atención al detalle Valorable
- Experiencia en entorno pharma, bajo normativa GMP
- Conocimiento de eCTD u otros formatos regulatorios
- Experiencia en mercados internacionales
Se ofrece
- Incorporación a una compañía consolidada
- Entorno dinámico y colaborativo
- Posibilidades de desarrollo profesional
- Condiciones salariales competitivas según experiencia
Oferta de empleo publicada Hace 2 meses
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