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
- Global Regulatory Strategy Lead at Grifols, overseeing regulatory strategies in R&D for healthcare solutions. Leading interactions with global regulatory authorities to expedite approvals.
Responsibilities
- Lidera el grupo de Estrategia Regulatoria para productos asignados
- Supervisa y/o participa en el desarrollo e implementación de programas regulatorios mundiales para el desarrollo de nuevos productos o nuevas indicaciones
- Coordina las actividades del departamento con funciones relacionadas, por ejemplo, Asuntos Regulatorios
- Representa al departamento en equipos transversales de alto nivel
Requirements
- Ph.D., Pharm. D., M.D. o equivalente
- 8 años de experiencia directa en Investigación Médica, Clínica, Asuntos Regulatorios u otras áreas críticas dentro de la industria farmacéutica
- Inglés fluido
- Conocimiento integral y comprensión de los requisitos regulatorios de la FDA y globales para la industria biotecnológica y farmacéutica
- Experiencia profunda en desarrollo clínico, diseño de ensayos, principios estadísticos
Benefits
- Flexibilidad para U Program: Modelo hibrido
- Horario flexible: Lunes-Jueves 7-10 a 16-19h y Viernes 8-15h (con el mismo horario de inicio flexible)
- Paquete de beneficios
- Contrato de Empleo: Posición permanente
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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