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Regulatory Affairs Technician

hace 3 meses

Madrid, Madrid, España Oxford Global Resources A tiempo completo

Regulatory Affairs Technician:

  • Location:
Madrid, Spain

  • Contact:
Susagna Sastre Magem

  • Job type:
Permanent

  • Contact phone:
  • Industry:
Pharmaceutical, Life Sciences, Biotechnology


Oxford Global Resources en colaboración con Laboratorio Farmacéutico Español con fabricación y presencia y distribución internacional busca un Regulatory Affairs Officer para sus oficinas a Madrid.

Se trata de una posición on-site lunes a jueves y con posiiblidad los viernes home-based.

Descripción del puesto de trabajo:


Reportando a Dirección de Registros como Técnico de Registros serás responsable de gestionar los registros nacionales, precio y financiación, farmacovigilancia, publicidad, cosméticos y productos sanitarios y licencias in-out y materiales de la organización.


Responsabilidades:

  • Revisión/ transformación eCTD de los expedientes de nuevos registros y elaboración del módulo
  • Elaboración de Revalidaciones quinquenales
  • Elaboración de los escritos de convalidaciones anuales
  • Elaboración de modificaciones/variaciones de registro
  • Elaboración de transferencias de registro
  • Solicitud de anulaciones de registro
  • Composición y elaboración de alegaciones de registro, DLs.
  • Corrección de errores y manejo de RAEFAR y fraccionamientos
  • Negociación fase local de textos con Sanidad una vez aprobado por CODEM.
  • Coordinación Test de Legibilidad.
  • Responsable de las Tareas de comunicación organismos para lanzamiento y mantenimiento CIMA, nomenclátor, bot plus y comunidades
  • Participar en los controles de cambios y sentar estrategias de implementación
  • Modificaciones, alteraciones y anulaciones a la oferta de la seguridad social. Control anual del proyecto de precios del ministerio
  • Presentación de Informes Periódicos de Seguridad (IPS)
  • Mantenimiento y notificación para sus productos al xEVMPD
  • Solicitud de autorización del Control Publicitario Sanitario (CPS) en OTC
  • Comunicación de todo tipo de publicidad a los organismos oficiales.
  • Revisión del material publicitario
  • Creación de las FT con precio y reembolso de los ICTM 5. Cosméticos y Productos Sanitarios
  • Solicitud de Códigos Nacionales para Cosméticos
  • Notificaciones de puesta en el mercado de Food supplements CAM
  • Relaciones con Terceros (Licencias) y coordinación de variaciones, nuevas MAA y trámites Sanitarios con respecto a estos.
  • Auditorias de dosieres/licencias
  • Revisión packaging material (Mock ups) de sus productos para puesta en mercado

Educación

  • Licenciado / Grado en Farmacia Máster en Regulación Farmacéutica
  • Experiência y Conocimientos: 5 años es dpto. de Registros de laboratorio Farmacéutico
  • Experiência en materia de materiales promocionales
  • Manejo de CTD, eAF, CESP Habituado a la relación con Ministerio de Sanidad, Colegio de Farmacéuticos, Consejo General del Colegio de Farmacéuticos, Comunidades Autónomas, Otros laboratorios, AEMPS/EMA, AEFI, AESEG

Se ofrece:

  • Contratación interinidad 12 meses con posibilidades reales de incorporación indefinida.
  • Comedor de Empresa
  • Teletrabajo 1 día a la semana