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 global 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 integral 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 an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case

📌 Senior regulatory affairs (Madrid)
🏢 Pqe Group
📍 Madrid