Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
About the role
- Regulatory Affairs Specialist preparing and managing product registrations at Grifols, a global healthcare leader in plasma-derived medicines. Collaborating with global teams to ensure compliance and accuracy in filings.
Responsibilities
- Preparar, revisar y gestionar envíos complejos y seguimiento de registros de productos
- Comunicar con afiliados, empresas externas y autoridades de salud
- Representar la función regulatoria en equipos de proyecto relacionados con registros de productos a nivel mundial
- Adaptar licencias a las regulaciones actuales
- Mantener un seguimiento de los registros de productos
- Apoyar a otros Departamentos, Afiliados y Terceros en cualquier información regulatoria requerida
- Crear políticas y procedimientos de asuntos regulatorios
Requirements
- Título universitario en Ciencias de la Vida
- Preferiblemente 2 años de experiencia técnica y/o regulatoria en la industria farmacéutica o combinación equivalente de educación y experiencia
- Experiencia valiosa con las leyes y regulaciones de registros de productos regulados
- Experiencia valiosa en envíos eCTD/CTD y gestión del ciclo de vida de los documentos
- Nivel avanzado de inglés
- Usuario de herramientas de Microsoft Office
- Detallista y minucioso
Benefits
- Flexibilidad horaria: lunes-jueves de 7-10 a 16-19h y viernes de 8-15h
- Contrato de Trabajo: Indefinido
- Programa de Flexibilidad U
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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