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)
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