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Regulatory Affairs Specialist

hace 1 mes

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Objetivo:
Planificar, implementar y monitorear las estrategias regulatorias para asegurar el mantenimiento del portafolio de los productos bajo su responsabilidad, así como para el registro de nuevos productos según las normativas vigentes en los mercados de Centroamérica y Caribe.
**Responsabilidades**:

- Coordinar, evaluar y preparar la documentación legal, técnica y/o clínica según los requisitos sanitarios vigentes.
- Supervisar y coordinar el servicio oportuno y eficaz de los agentes regulatorios en la región.
- Analizar observaciones/prevenciones emitidas por las Autoridades Regulatorias y gestionar la estrategia para subsanarlas con los agentes locales y el equipo global.
- Mantener comunicación asertiva y oportuna con los equipos de Mercadeo, Ventas, Demanda y Calidad, entre otros, así como con los equipos globales.
- Seguimiento periódico de los cambios en las legislaciones regulatorias de Centroamérica y Caribe.
- Asesorar en materia regulatoria a las diferentes áreas de la compañía relacionadas con el desarrollo, producción, control, distribución y comercialización de los productos.
- Mantener actualizadas las diferentes bases de datos según los procedimientos de la compañía con el fin de garantizar las Buenas Prácticas Regulatorias.
EDUCACIÓN, CALIFICACIONES, HABILIDADES Y EXPERIENCIA:
Esenciales
- Experiência en los principales procesos regulatorios de medicamentos de síntesis química (inscripción, renovación, cambios post-registro) de al menos 2 años en la región de Centroamérica y Caribe
- Grado Universitario o Licenciatura en Farmacia y estar incorporado al Colegio de Farmacéuticos de Costa Rica
- Dominio del idioma inglés (intermedio-avanzado), oral y escrito
- Habilidad con el manejo del paquete de Microsoft Office y otras herramientas informáticas.
- Enfoque en el desempeño
- Buena planificación y manejo del tiempo
- Integridad y valores éticos
- Respeto hacia el individuo y la diversidad
- Confianza y habilidad para trabajar en equipo
- Enfoque en el cliente interno y externo
- Habilidades de negociación
**Deseables**
- Pensamiento creativo
- Habilidades de liderazgo
- Conocimientos de los principales procesos regulatorios de medicamentos biológicos (inscripción, renovación, cambios post-registro) en la región de Centroamérica y Caribe
- Conocimiento de las regulaciones de Autoridades Regulatorias Estrictas como FDA y EMA