Are you ready to join aworld leaderin the exciting and dynamic fields of thePharmaceutical and Medical Device industries? PQE Grouphas been at the forefront of these industriessince 1998, with40 subsidiariesand more than2000 employees in Europe, Asia and the Americas.We are seeking aSenior Regulatory Affairs & Pharmacovigilance Specialistto support bothlocalandinternationalregulatoryandPV activities. The role combines hands-onregulatory workwithpharmacovigilance oversight, ensuring compliance acrossSpainandLATAMmarkets.Key ResponsibilitiesRegulatory Affairs (RA):Analyze EU regulatory strategiesand provide recommendations to clientsAuthor full technical dossiers(Modules 1–5) from scratchManage variations, renewals, labeling updates, andHealth Authority interactionsSupportregulatory activities in LATAM marketsCollaborate withglobal teamsandinternational clientsPharmacovigilance (PV):SupportPV activitiesandreporting obligationsinSpainandEUEnsure compliance withlocal and international safety regulationsAssist insignal detection,risk management,



andsafety documentationCoordinate withglobal PV teamsto alignprocessesandreportingRequirements4–5 years of experience inRegulatory Affairsand/orPharmacovigilanceinpharmaorconsultancyStrong knowledge ofEUandSpanish regulationsExperience inglobalorcorporate regulatory/PV environmentsFluency inSpanishandEnglish(C1–C2);
Nice-to-Haveknowledge ofItalianand/orPortugueseExperience withLATAM regulatory/PV activitiesExposure toMedical Devices,Veterinary,Cosmetics, orFood SupplementsStrong interest in or experience withpharmacovigilance systemsandprocessesSalary 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 Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.Working at PQE GroupAs a member of the PQE team, you will be part of achallenging, multicultural company that values collaboration and innovation

📌 Senior Regulatory Affairs & Pharmacovigilance Specialist (Barcelona)
🏢 Pqe Group
📍 Barcelona