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 ResponsibilitiesRegulatory Affairs (RA):Analyze EU regulatory strategies and provide recommendations to clientsAuthor full technical dossiers (Modules 1–5) from scratchManage variations, renewals, labeling updates, and Health Authority interactionsSupport regulatory activities in LATAM marketsCollaborate with general teams and international clientsPharmacovigilance (PV):Support PV activities and reporting obligations in Spain and EUEnsure compliance with local and international safety regulationsAssist in signal detection, risk management,



and safety documentationCoordinate with global PV teams to align processes and reportingRequirements4–5 years of experience in Regulatory Affairs and/or Pharmacovigilance in pharma or consultancyStrong knowledge of EU and Spanish regulationsExperience in global or corporate regulatory/PV environmentsFluency in Spanish and English (C1–C2); Nice-to-Have knowledge of Italian and/or PortugueseExperience with LATAM regulatory/PV activitiesExposure to Medical Devices, Veterinary, Cosmetics, or Food SupplementsStrong interest in or experience with pharmacovigilance systems and processesSalary starting from €35,000 gross per yearNext StepsUpon 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 of a positive outcome coming from

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