Regulatory Affairs Senior Manager
hace 2 semanas
Empresa multinacional, con una rápida expansión gracias a su alta tecnología innovadora y de acceso para especialidades de alta complejidad
Descripción de la vacante
Principales Responsabilidades: 1. Participar y abogar con grupos externos de la industria para implementar regulaciones que beneficien a la industria y la salud pública.2. Desarrollar e incentivar estrategias regulatorias alternativas para beneficiar al negocio.
3. Gestionar la estructura organizativa del proceso para la eficiencia operativa.
4. Desarrollar e implementar planes para el desarrollo profesional del equipo.
5.Asegurar que las estrategias regulatorias se implementen para mantener el cumplimiento de los requisitos regulatorios nacionales y regionales.
6. Asesorar a equipos interfuncionales sobre los requisitos regulatorios y ayudar con la interpretación e implementación de regulaciones.
7.Gestionar el equipo de Asuntos Regulatorios para optimizar la preparación de expedientes regulatorios alineados con la estrategia comercial.
8. Asegurar que el equipo se prepare eficientemente para evaluaciones regulatorias por cambios en productos existentes.
9. Mantenerse al tanto de los cambios en los requisitos regulatorios y las tendencias de la industria que podrían afectar a la organización.
10. Construir relaciones sólidas y abogar con autoridades regulatorias y participar en reuniones y negociaciones.
Perfil del candidato
Deberás contar con:
1. Base en la Ciudad de México
2. Al menos 5 años de experiencia como Manager
3. Mínimo de 10 años de experiencia en asuntos regulatorios en la industria de dispositivos médicos o farmacéutica.
4. Conocimiento detallado de las regulaciones, guías y requisitos de COFEPRIS. El conocimiento de otros requisitos regulatorios internacionales y dinámicas de entes regulatorios es un plus.
5. Fuertes habilidades de comunicación, organización y gestión de equipos.
6. Experiencia en la gestión de equipos complejos. Altamente técnicos, multiculturales e influencia positiva a otros equipos.
7. Capacidad para orientar y mentorizar el desarrollo profesional de su equipo.
8. Capacidad para trabajar en un entorno de ritmo rápido con prioridades cambiantes y plazos ajustados.
9. Experiencia en la presentación de casos de negocio para proyectos y liderando su ejecución.
10. Experiencia trabajando con equipos de trabajo cross industria, participación en proyectos de mejora e implementación de procesos. participación con cámaras de comercio/de industria.
Habilidades Requeridas:
- Auto-dirigido
- Enfoque y atención al detalle
- Habilidades de relación con equipo y otras áreas
- Trabajo en equipo
- Capacidad de toma de decisión
- Relacinamiento de alto nivel
- Influencia positiva como Business Partner del negocio
- Capacidad resolutiva
- Estrategia a largo plazo
- habilidad tecnológica
Oferta de empleo
Alta probabilidad de crecimiento, paquete de compensación de salario base, más bonos, comisiones y beneficios superiores a la ley.Tendrás la posibilidad de potenciar tu carrera y tu experiencia de vida con una de las empresas e industrias con mayor potencial en la actualidad. Postúlate para tener la posibilidad de evaluar tu perfil y tener una gran oportunidad profesional
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