Regulatory Affairs Teamleader Hc Latam
hace 2 días
At Beiersdorf, we want to help people feel good about their skin - and our commitment goes far beyond caring for skin. For 140 years, we have developed innovative skin and body care products for well-known brands such as NIVEA, Eucerin, La Prairie, Hansaplast, and Labello. We act according to our purpose, WE CARE BEYOND SKIN, and take responsibility for our consumers, our employees, the environment and society.Behind every brand, every product and every accomplishment are our more than 20,000 employees. It is for them that we live a culture of inclusion, respect and trust that is strongly aligned with our values - CARE, COURAGE, SIMPLICITY and TRUST. We embrace diversity by valuing the uniqueness of each individual and being committed to equal opportunities for all.**Your Tasks**:- Asegurar la correcta ejecución de las estrategias regionales de Health Care en cada uno de los países de Latinoamérica a través del desarrollo y establecimiento de la estrategia regulatoria correcta y ágil para registro de dispositivos médicos y medicamentos.- Liderar y Coordinar con BSN Medical Cali la disponibilidad de todos los documentos requeridos para asegurar un proceso de registro, actualización o renovación exitoso del portafolio Curitas en países de Latinoamérica y algunos del Medio Oriente, así como de coordinar la correcta implementación de los artes aprobados para venta.- Responsable por asegurar y proporcionar información técnica y documentos legales necesarios para llevar a cabo los registros de los productos como dispositivos médicos o medicamentos en los diferentes países de Latinoamérica, brindando soporte y guía a los equipos regulatorios locales.- Responsable de coordinar la revisión regulatoria de artes para garantizar el cumplimiento con la legislación aplicable en cada uno de los países de Latinoamérica.- Responsable directo por la revisión y aprobación de artes, claims, material publicitario y promocional para asegurar que cumple con los lineamientos aplicables vigentes por COFEPRIS en México.- Responsable por obtener los registros sanitarios del portafolio de Health ante COFEPRIS en México, así como de mantener el plan anual de actualización, mantenimiento y renovación oportuna de los registros.- Responsable por obtener los permisos de importación, permisos de publicidad y avisos de publicidad ante COFEPRIS en México.- Informar de manera oportuna sobre los cambios en la legislación y normativa mexicana que puedan impactar de forma directa la importación, almacenamiento, distribución, comercialización y/o venta en México.- Mantener contacto directo con los equipos regulatorios locales para anticipar riesgos por cambio de sus regulaciones que puedan impactar la importación, almacenamiento, distribución, comercialización y/o venta en México y los países de Latinoamérica.**Your Profile**:- Carreras: Ciencias de la salud, farmacéutico, ingeniero químico, ingeniero industrial- Mínimo 3 años de experiência en posición similar- Inglés intermedio- Manejo de trámites Regulatorios ante COFEPRIS, registros sanitarios de Dispositivos Médicos y/o Medicamentos.- Conocimiento de la normatividad aplicable a dispositivos médicos y/o medicamentos en Latinoamérica.- Haber liderado proyectos que incluyan las regiones Andina, Centroamérica o Colombia.**Additional information**:
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