Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Experiencia, cualificaciones y habilidades interpersonales, ¿tiene todo lo necesario para triunfar en esta oportunidad? Descúbralo a continuación.

We are seeking a Senior Regulatory Affairs & Pharmacovigilance Specialist to support both local and international regulatory and PV activities . The role combines hands‑on regulatory work with pharmacovigilance oversight , ensuring compliance across Spain and LATAM markets.

Key Responsibilities
Regulatory Affairs (RA)

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- Analyze EU regulatory strategies and provide recommendations to clients

- Author full technical dossiers (Modules 1–5) from scratch

- Manage variations, renewals, labeling updates , and Health Authority interactions

- Support regulatory activities in LATAM markets

- Collaborate with global teams and international clients

Pharmacovigilance (PV)





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- Support PV activities and reporting obligations in Spain and EU

- Ensure compliance with local and international safety regulations

- Assist in signal detection , risk management , and 安全 documentation

- Coordinate with global PV teams to align processes and reporting

Requirements

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- 4–5 years of experience in Regulatory Affairs and/or Pharmacovigilance in pharma or consultancy

- Strong knowledge of EU and Spanish regulations xqbhyrx

- Experience in integral or corporate regulatory/PV environments

- Fluency in Spanish and English (C1–C2); Nice-to-Have knowledge of Italian and/or Portuguese

- Experience with LATAM regulatory/PV activities

- Exposure to Medical Devices , Veterinary , Cosmetics , or Food Supplements

- Strong interest in or experience with pharmacovigilance systems and processes

- Salary starting from €35,000 gross per year

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📌 Senior Regulatory Affairs & Pharmacovigilance Specialist (Barcelona)
🏢 Pqe Group
📍 Barcelona