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.
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)
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)




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
4–5 years of experience in Regulatory Affairs and/or Pharmacovigilance in pharma or consultancy
Strong knowledge of EU and Spanish regulations
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