Regulatory Affairs Specialist

hace 2 días


Barcelona, Barcelona, España Ferrer Internacional Sa A tiempo completo
Regulatory Affairs Trainee

Ferrer Internacional Sa busca un/a Regulatory Affairs Trainee para unirse a nuestro equipo de profesionales comprometidos con la innovación y el desarrollo de productos farmacéuticos de alta calidad.

Funciones clave:
  • Gestionar la preparación, presentación y mantenimiento de las autorizaciones de comercialización de los medicamentos y resto de productos de la compañía.
  • Generar y recopilar toda la información interna y externa para la evaluación o mantenimiento de los dossiers.
  • Seguimiento de los dossiers presentados a registro ante las autoridades correspondientes en cada país siguiendo la estrategia regulatoria de la compañía.
  • Mantenimiento y actualización de los dossiers de registro (variaciones y revalidaciones quinquenales).
  • Dar soporte en las ofertas y auditorías de posibles licenciadores y licenciatarios, desde el punto de vista técnico (calidad del dossier, plazos, procedimientos, etc.).
  • Mantener un conocimiento actualizado de la normativa publicada y de aplicación en el ámbito de registros de todas las categorías de productos, así como prestar soporte a los diferentes departamentos implicados.
  • Mantener las bases de datos del departamento.
Requisitos:
  • Formación académica: Licenciatura en ciencias de la salud (Química, Farmacia, Bioquímica, Biología).
  • Idiomas: Español e Inglés nivel avanzado hablado y escrito.
  • Informática: A nivel de usuario.
  • Necesarias buenas capacidades de relación, comunicación, aprendizaje, adaptación, flexibilidad y espíritu crítico.
Condiciones propuestas:
  • Horario: De lunes a jueves jornada completa 9-18h. Viernes jornada intensiva de 9-14h.


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