Regulatory Intelligence

hace 7 meses

Lima, Perú AstraZeneca A tiempo completo

¿Tienes experiência y pasión por el área regulatoria? ¿Te gustaría aplicar tu experiência para impactar en una empresa que sigue la ciencia y convierte las ideas en medicamentos que cambian la vida? Entonces AstraZeneca podría ser la empresa indicada para ti_

En el Clúster Andino tenemos una gran oportunidad en la ciudad de Lima - Perú, 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 experiência 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 experiência 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.
- Te invitamos a postularte a AstraZeneca una empresa enfocada en ser un Gran Lugar para Trabajar. Donde tienes el poder de retar los límites de la ciencia y dar rienda suelta a tu espíritu emprendedor. No hay mejor lugar para marcar la diferencia en la medicina, los pacientes y la sociedad. Una cultura inclusiva que defiende la diversidad y la colaboración; siempre comprometida con el aprendizaje, el crecimiento y el desarrollo a lo largo de toda la vida. Estamos en un viaje emocionante para ser pioneros en el futuro de la atención médica._

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