Third Parties Regulatory Affairs Manager
hace 2 semanas
Su misión será la de realizar todas las actividades regulatorias necesarias para garantizar que la autorización de comercialización y el mantenimiento de las autorizaciones del portfolio, se producen en las condiciones óptimas para el Negocio, cumpliendo con la legislación vigente y normativa corporativa.
Entre sus funciones, destacamos:
- Colaboración con Jefe de Área en la propuesta y decisión de la estrategia regulatoria a seguir de acuerdo a la política comercial del Negocio Farmacéutico en las distintas acciones de registro requeridas.
- Preparación de dosieres de registro/documentación para la comercialización de medicamentos desarrollados o codesarrollos (facilitar documentación técnica para Autoridades Sanitarias en los diferentes países; corrección de deficiencias identificadas durante la evaluación de los dosieres; presentar documentación de variaciones de productos -propios y licencias a terceros
- nacional e internacionalmente; gestión y seguimiento de precios).
- Actualizar las Bases de Datos y aplicaciones informáticas del Área y Organismos Oficiales para mantenerla completa y vigente.
- Colaborar con Farmacovigilancia (facilitar información de autorización, cancelación, variaciones de productos, resultados de actividades de FV, restricciones, suspensiones, etc.).
- Firmar documentación técnico-sanitaria relacionada con Registros, Dirección Técnica del Negocio, documentos de exportación u otros para dar continuidad a las actividades.
- Representar a la Empresa ante las AASS que evalúan o intervienen en el registro y comercialización de los productos.
- Soporte a colaboradores de otras áreas del Grupo.
- Colaboración en equipos multidisciplinares o Comités Internos de trabajo.
- Supervisar o realizar gestiones internas necesarias (solicitudes de cambio, circuitos de alta, circuito de materiales, listados internos, etc.).
- _Contratación indefinida_
- _Horario partido flexible (jornada mínima 6h/día + viernes intensivo) + 1 día de teletrabajo (posibilidad 2 mitades de día)._
- _Beneficios Sociales: Ticket restaurant + Plan Compensación Flexible (Transporte, Seguro de Vida..)._
**Requisitos**:
- Licenciatura o Grado en Farmacia o similar.
- Valorable Master o Postgrado en Industria Farmacéutica, Registros o similar.
- Nível inglés C1.
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