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 general 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 xcskxlj

- Experience in global 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