senior regulatory affairs specialist

hace 1 semana


Sant Joan Despí, Barcelona, España ARTHADA A tiempo completo

ARTHADA, empresa líder en ofrecer servicios especializados de recursos humanos al sector farmacéutico, selecciona para un importante grupo Químico-Farmacéutico internacional en el área de los Genéricos un

SENIOR REGULATORY AFFAIRS SPECIALIST

Se responsabilizará de la elaboración de los expedientes de registro de especialidades farmacéuticas genéricas para aquellos países dónde la empresa o sus clientes deseen comercializar sus productos, principalmente entorno EMA y FDA. Mantendrá el contacto con los departamentos internos de la compañía y las empresas cliente. Asimismo, se ocupará de las variaciones y renovaciones. Responderá a las deficiency letters.

  • Licenciatura en Ciencias de la Vida.
  • Experiencia redactando dosieres de registros de productos farmacéuticos, principalmente módulo 3.
  • Experiencia en entorno EMA y/o FDA.
  • Capacidad de trabajo y dinamismo.
  • Dotes de planificación y organización.
  • Elevada capacidad de comunicación y trabajo en equipo.
  • Imprescindible inglés fluido.


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