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Técnico Regulatory Affairs

hace 4 semanas

Castelló de la Plana, Castellón, España Tn Spain A tiempo completo

Técnico Regulatory Affairs, Castellón de la Plana Ubicación: Castellón de la Plana, Spain
Tu nueva empresa: Reconocida compañía farmacéutica con presencia internacional.

Tu nuevo puesto: Te incorporarás como Técnico de Regulatory Affairs y tus responsabilidades diarias incluirán:
Revisar expedientes y colaborar con el departamento de Marketing y la sede de la compañía.
Apoyar a clientes con información regulatoria y técnica sobre los productos.
Preparar y enviar expedientes a las autoridades sanitarias en la UE, siguiendo los procedimientos aplicables.
Contactar a las autoridades sanitarias europeas para dar seguimiento a las presentaciones y coordinar estrategias de RA con clientes europeos.
Revisar y responder a cartas de deficiencia de las autoridades sanitarias.
Publicar eCTD y mantener adecuadamente los expedientes, incluyendo PSUR, variaciones y renovaciones.
Mantenerse actualizado con los requisitos regulatorios en la región.
Realizar actividades de farmacovigilancia seleccionadas.
Apoyar en la elaboración de acuerdos de calidad y la liberación de productos.
Proponer, elaborar e implementar nuevos procedimientos.
Requisitos para encajar con el puesto: Grado en Ciencias de la Salud (Farmacia, Química o similares).
Idealmente entre 3-5 años de experiencia en el Departamento de Asuntos Regulatorios de una empresa farmacéutica.
Se valorará experiencia con procedimientos a nivel internacional.
Conocimiento de GMP y farmacovigilancia es una ventaja.
Fluidez en inglés, tanto escrito como hablado.
Lo que obtendrás a cambio: Contrato indefinido.
Paquete de beneficios adicionales.
Modelo de trabajo híbrido.
Horario flexible.
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