Regulatory Affairs Consultant (9-months contract)

Madrid Temporal EUR70.000 - EUR80.000 por año Ver descripción del puesto
We are recruiting a Regulatory Affairs Consultant for a 9‑months temporary assignment to support regulatory activities for marketed products and assist with the preparation and maintenance of regulatory documentation for national and European procedures.

Actualizado el 30/03/2026

  • Drive compliant regulatory submissions in a fast‑paced global environment.
  • Ensure cross‑functional alignment to accelerate regulatory deliverables.

¿Dónde vas a trabajar?

Our client is a Global biopharmaceutical multinational, leader in industry.

Descripción

  • Review promotional and non-promotional materials in accordance with the Company internal promotional guidelines, national regulations and Codes of Practice. Provision of guidance and assistance to Marketing during preparation of promotional material.
  • Cross functional interactions with Business Unit, Medical and other departments if required. Provision of regulatory advice, as applicable.
  • Translation of Regulatory documents. Submission and follow-up of regulatory submissions to national authorities, as well as the variations to product information in centralized procedures,acting as a Liaison with Int RA for those activities, as required.
  • Revision of regulatory documents: outer cartons, labels and leaflets of Firm's marketed products and clinical trials.
  • Review of tender documentation and regulatory dossiers, as required.
  • Submission of clinical trials amendments and notifications to competent authorities of the clinical trials under his/her responsibility, as applicable.
  • Regulatory Intelligence: Competitors, new regulations or other relevant information.
  • Quality topics: Knowledge of applicable regulations, preparation and update of Quality SOPs, management of complaints and other quality topics.
  • Creation and update of SOPs and associated process documentation as required.

¿A quién buscamos (H/M/D)?

A successful Regulatory Affairs Consultant should have:

  • University degree in Health Sciences (e.g. Pharmacy or similar).
  • A Master's degree in Regulatory Affairs or equivalent is considered a plus.
  • 5+ years of experience in Regulatory Affairs, preferably in an affiliate environment.
  • Experience in the review of promotional and non‑promotional materials, in accordance with applicable regulations and Codes of Practice.
  • Knowledge of regulatory procedures, including registration and maintenance activities.
  • Experience working in direct contact with Health Authorities is considered a plus.

¿Cuáles son tus beneficios?

  • 9‑months temporary contract.
  • Opportunity to join a top-tier American biopharma multinational.
  • Competitive salary: €70.000 - €80,000 gross/year, depending on experience.
  • Hybrid working model and international exposure.
  • Immediate start
Ver más ofertas de empleo
Ignacio Mora
Indicar número de referencia para la oferta
JN-032026-6974929

Resumen de empleo

Sector
Healthcare
Sub Sector
Registros
Añadir industria
Healthcare / Pharmaceutical
Localización
Madrid
Tipo de Contracto
Temporal
Nombre del consultor
Ignacio Mora
Número de referencia
JN-032026-6974929

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