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.
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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 integral 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 safety 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
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for

📌 Senior Regulatory Affairs (Barcelona)
🏢 Pqe Group
📍 Barcelona