Regulatory Intelligence

hace 2 semanas


Bogotá, Bogotá D.E., Colombia AstraZeneca A tiempo completo

En el Clúster Andino tenemos una gran oportunidad en la ciudad de Bogotá - Colombia, en el rol de Regulatory Intelligence & GRP Lead Clúster Andino. Esta posición tiene la responsabilidad de garantizar la alineación de los procesos regulatorios de la compañía a la regulación vigente y los requerimientos asociados , participar activamente en el análisis de proyectos de regulación , nuevas regulaciones o cambios a la regulación actual con impacto en el proceso de registro, importación y comercialización de los productos de la compañía en el Clúster Andino (Colombia, Peru, Ecuador y Venezuela) y del proceso de inteligencia regulatoria aplicable a productos y procesos regulatorios aplicables, así mismo será el responsable de asegurar el cumplimiento regulatorio (GRP) para el clúster andino en cumplimiento con las políticas de AZ y las regulaciones locales.

Requisitos para el rol

Profesional químico farmacéutico. Conocimiento de la regulación local aplicable a registro, importación y comercialización de medicamentos en Colombia, Peru y Ecuador (deseable en Venezuela también) Mínimo 4 a 6 años de experiencia en la industria farmacéutica definiendo y/o soportando procesos regulatorios relacionado con los procesos ante autoridades regulatorias del clúster andino. Inglés Avanzado (Listening, Speaking, Reading) Pensamiento estratégico Propositivo e Innovador Habilidades en toma de decisiones Buena comunicación oral y escrita Habilidades de planeación y seguimiento Conocimientos y experiencia en sistemas de gestión de calidad GXP/GRP.

Responsabilidades Principales

Cumplir con los estándares establecidos para el cargo en los procesos locales aplicables. Ser punto de contacto con el equipo global y local para la confirmación de requisitos regulatorios asociados a tramites de registro sanitario y procesos de importación y comercialización de los productos en los mercados del clúster andino. Definir los procesos de seguimiento, actualización y reporte de novedades de inteligencia regulatoria para nuevas regulaciones, cambios en la regulación o proyectos que impacten los procesos regulatorios o requerimientos aplicables para los países del clúster andino Establecer el proceso de seguimiento, actualización y reporte de novedades de inteligencia regulatoria para productos competidores de los productos de la compañía en el clúster andino Establecer y mantener la herramienta de inteligencia regulatoria para el clúster andino y establecer lineamientos para actualización y reportes a las áreas cros funcionales Actuar como back-up del Head de Asuntos Regulatorios, otros leads de asuntos regulatorios o analista de asuntos regulatorios según se requiera.

Date Posted

13-jun-2024

Closing Date

24-jun-2024
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