Regulatory Affairs Analyst
hace 3 semanas
**Descripción empresa**:
TRABAJAMOS CADA DÍA PARA SER UN PROVEEDOR COMPLETO PARA EL CUIDADO DE LA SALUD.
En B. Braun desarrollamos soluciones eficientes y buenas prácticas para el cuidado de la salud gracias a un diálogo constructivo con nuestros clientes y colaboradores.
A través de una estrecha relación y cooperación con los profesionales de la salud combinamos nuestros servicios y productos para ofrecer soluciones inteligentes y eficientes que cubran terapias completas y nos permitan seguir creciendo juntos.
**Misión del cargo**:
Garantizar el cumplimiento de las actividades planeadas para la radicación de expedientes de registros sanitarios presentados ante el INVIMA
**Funciones del cargo**:
Solicitar en conjunto con el jefe del departamento los documentos requeridos para realizar los trámites propios del área como la renovaciones, modificación y nuevos registros sanitarios.
Elaboración de expedientes para las solicitudes de los registros sanitarios de medicamentos, dispositivos médicos, cosméticos, alimentos regulares y alimentos con propósitos médicos especiales APME bajo la coordinación del jefe del departamento.
Asegurar mitigar el riesgo de cancelación y/o suspensión de registros sanitarios asegurando las acciones para evitar poner en riesgo la venta de los productos de la compañía.
Verificar constantemente el correo de asuntos regulatorios donde el INVIMA notifica los actos administrativos de los tramites relacionado con la compañía.
Organizar y garantizar el correcto archivo de los expedientes de los productos radicados ante INVIMA.
Elaborar y presentar al jefe inmediato los informes del estado de trámites ante INVIMA.
Elaborar las fichas técnicas y hojas de productos (que apliquen) de los productos registrados y comercializados por BBMCO, para la aprobación por parte del jefe del departamento.
Creación, modificación de los documentos en SAP de los materiales relacionados con los registros sanitarios (COI), clientes autorizados para comercializar medicamentos de control especial (COC), venta de medicamentos de BBMCO (COF), previa delegación y autorización del jefe del departamento.
Diligenciamiento de los formatos para solicitud de pago ante INVIMA y traducciones, archivándolos en la carpeta correspondiente.
Actualización de la información de registros y demás documentos en las bases de datos de asuntos regulatorios cada vez que se expida algún trámite al departamento.
Colaborar con el jefe del departamento en el seguimiento y control del presupuesto de la unidad de negocio a cargo.
Autorizar en SAP los clientes que cumplen con la regulación para la compra de medicamentos de control especial.
**Requisitos**:
2 o 3 años de experiência en Asuntos Regulatorios en compañías farmacéuticas o de alimentos.
Profesional en Química Farmacéutica.
Ingles nível intermedio (B2), Office intermedio.
**Condiciones oferta**:
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