Técnico De Regulatory Affairs

hace 1 semana


Madrid, Madrid, España Antal International Network A tiempo completo
Desde Antal International estamos buscando un técnico de registros para un laboratorio farmacéuticoubicado en Madrid.

Este profesional tendrá como responsabilidad principal la gestión de la documentación necesaria para la consecución de los registros/autorizaciones de puesta en el mercado de los nuevos medicamentos de la compañía así como la gestión y seguimiento del mantenimiento de los registros ya existentes según la normativa vigente.


Funciones:
Preparar la documentación requerida para los procedimientos de registro,renovación, variación y otros Redactar textos generales e informes para nuevos registros, variaciones y renovaciones de registro Participación en proyectos para el desarrollo de nuevos productos o actualización de los existentes Mantenerse actualizado en novedades legislativas y otros requerimientos de los diferentes mercados Colaborar en solicitudes de nuevos registros, variaciones y renovaciones de registros inmunológicos en Exportación Mantener comunicación actualizada y coordinación con otros departamentos/áreasen todo lo relacionado con Registros Funciones de Farmacovigilancia: formar parte de la Unidad de Farmacovigilancia, cuando se requiera, asumiendo la función de suplente de

Farmacovigilancia Reguisitos:
Formación universitaria en ciencias de la salud Experiencia previa en puesto similar de más de 1 año Conocimiento de la normativa específica reguladora de industria farmacéutica Nivel de inglés alto (C1)
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