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Interim Senior Regulatory Affairs Officer

Barcelona Temporal EUR50.000 - EUR60.000 por año View Job Description
Responsible for performing, reviewing and approving local regulatory affairs activities, with especial focus in the Spain registration process for allergen medicines (Orden Ministerial SND/778/2023).
  • Guardar

Added 17/12/2024

  • Vaccines - Local RA
  • 1 Year Contract

¿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
  • 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
  • To comply with all Good Regulatory Practices, refer to formalized, mandatory policies that define common and transparent rules for regulatory agencies.
  • To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and Others.
  • To control and maintain your personal training folder.
  • To comply with all Company policies and procedures.
  • To follow a code of conduct conducive to a professional environment

¿A quién buscamos (H/M/D)?

  • Life sciences degree related to the activity Minimum of 8 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
  • Flexible shift
  • Barcelona based
  • 1 year contract
Ver más ofertas de empleo
Cristian Atik
Indicar número de referencia para la oferta
JN-122024-6615462

Resumen de empleo

Sector
Healthcare
Sub Sector
Departamento Médico
Industria
Healthcare / Pharmaceutical
Localización
Barcelona
Tipo de Contracto
Temporary
Nombre del consultor
Cristian Atik
Número de referencia
JN-122024-6615462

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