Regulatory Affairs Spain

Madrid Permanente EUR40.000 - EUR45.000 por año Ver descripción del puesto
Responsible for performing, reviewing and approving local regulatory affairs activities, with especial focus in the Spain registration process for vaccine medicines (Orden Ministerial SND/778/2023).

Actualizado el 24/10/2025

  • Vaccines - Local RA
  • Madrid or Barcelona based

¿Dónde vas a trabajar?

International Pharmaceutical Company

Descripción

  • Ensure regulatory systems, such as Regulatory Database/trackers are implemented and kept up to date.
  • Work with internal & external customers to provide data and accurate regulatory input.
  • Prepare & review labelling/Packaging texts and information brochures and communication activities.
  • Run regulatory local projects meeting timelines and costs
  • Understand relevant legislative and regulatory guidance applicable to activities of the company
  • Prepare risk benefit analysis
  • Active involvement in concepts of regulatory strategy
  • Attend industry and RA meetings
  • Communicating with local regulatory agencies and document communication
  • Provide local RA support to local Sales, Customer Services, QA, LSO, Medical and Marketing depts.
  • Prepare and update local SOPs

¿A quién buscamos (H/M/D)?

  • Life sciences degree related to the activity Minimum of 4 years in the regulatory pharmaceutical field (preferred experience with biological products)
  • Demonstrated ability to write good quality documents
  • Highly PC literate
  • Project management abilities
  • Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
  • Fluency in English language

¿Cuáles son tus beneficios?

  • Flexible hybrid model (up to 4 days home office), during trial period non applicable.
  • Flexible shift
  • Madrid (Alcalá Henares) or Barcelona (St Joan dEspi)
  • Social benefits
Ver más ofertas de empleo
Cristian Atik
Indicar número de referencia para la oferta
JN-102025-6864003

Resumen de empleo

Sector
Healthcare
Sub Sector
Registros
Añadir industria
Healthcare / Pharmaceutical
Localización
Madrid
Tipo de Contracto
Permanent
Nombre del consultor
Cristian Atik
Número de referencia
JN-102025-6864003

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