Regulatory Affairs Coordinator
hace 1 mes
Coordinación de Presentaciones Regulatorias : Asegurar la preparación y presentación de los registros y documentos regulatorios para productos farmacéuticos y dispositivos médicos en Chile y SOLA, cumpliendo con los plazos establecidos.
Supervisión de Consultores y Distribuidores : Gestionar y supervisar a los consultores locales y distribuidores en América Latina, asegurando el cumplimiento de las normativas y la correcta tramitación de las solicitudes regulatorias.
Interacción con Autoridades Regulatorias : Colaborar con los organismos regulatorios locales y nacionales, coordinando estrategias para obtener aprobaciones rápidas y gestionando los impactos de cualquier cambio en las normativas.
Mantenimiento del Ciclo de Vida del Producto : Gestionar y actualizar los documentos relacionados con el ciclo de vida de los productos, como renovaciones, variaciones, notificaciones y registros nuevos, asegurando la conformidad con las regulaciones.
Liderazgo y Formación : Desarrollar y coordinar programas de formación sobre asuntos regulatorios, mantener procedimientos internos conforme a la legislación vigente, y asumir el rol de Director Técnico ante las autoridades sanitarias locales.
Estamos en la búsqueda de un candidato ideal con más de 5 años de experiencia en el área regulatoria, especialmente en los sectores farmacéutico y de dispositivos médicos. El perfil que buscamos debe contar con un sólido conocimiento de las regulaciones nacionales e internacionales, incluyendo Buenas Prácticas de Distribución, y tener un enfoque particular en la normativa de América Latina, especialmente en Chile.
El candidato debe ser capaz de gestionar equipos, coordinando consultores externos y distribuidores en la región de manera eficiente. Buscamos a alguien organizado, meticuloso y con capacidad para gestionar múltiples proyectos simultáneamente, siempre asegurando el cumplimiento de las normativas locales y globales. Es importante que tenga fluidez en inglés y que pueda trabajar en un entorno multicultural y con una estructura de reportes matricial. Se valorará positivamente la experiencia previa como Director Técnico. Además, el candidato deberá tener experiencia en la gestión del ciclo de vida de los productos, incluyendo registros, renovaciones y aprobación de materiales promocionales, y la capacidad de interactuar con las autoridades regulatorias locales para asegurar aprobaciones oportunas.
Empresa multinacional del sector farmacéutico, con presencia en América Latina, enfocada en la producción y distribución de productos farmacéuticos y dispositivos médicos.
Se ofrece formar parte de una importante empresa, que promueve la innovación y el desarrollo del capital humano, en el que te permitirá desarrollarte y donde podrás aportar con tu talento y experiencia. Súmate a este desafío
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Regulatory Affairs Specialist
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Project Director
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Regulatory Affairs Country Lead
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist Chile
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Analyst
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Regulatory Affairs Specialist, Export Countries
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Project Director for Regulatory Affairs
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Highly Experienced Senior Project Manager
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