PAre you ready to join a bworld leader /b in the exciting and dynamic fields of theb Pharmaceutical and Medical Device industries? PQE Group /b has been at the forefront of these industries bsince 1998 /b, with b40 subsidiaries /b and more than b2000 employees in Europe, Asia and the Americas. /b /ppbr/ppWe are looking for a bRegulatory Affairs Specialist /b to join our team and support regulatory activities across bEMEA and LATAM /b. This position is ideal for a professional with baround 3 years of experience in Regulatory Affairs /b, particularly with strong exposure to bCMC documentation and lifecycle management /b in multinational environments. /ppbr/pp❗ ❗ We offer a bfull-time employment contract based in Madrid /b, starting with a bone-year fully remote assignment /b on an international project, including boccasional travel to the client’s site in Alcobendas /b during the first year. /ppbr/ppResponsibilities include, but are not limited to: /pulliSupport regulatory submissions and activities across bEMEA and LATAM markets /b. /liliPrepare and maintain bregulatory dossiers /b, including bModule 1 and Module 3 /b documentation. /liliContribute to bCMC regulatory strategies /b and documentation. /liliManage blifecycle activities /b, including bvariations, renewals, and post-approval changes /b. /liliPrepare and review technical documentation such as bASMF and Quality Overall Summary (QoS) /b. /liliCoordinate regulatory submissions and ensure compliance with regional regulatory requirements. /liliSupport binteractions with health authorities /b and assist in addressing regulatory queries. /liliCollaborate with cross-functional and international teams in a bmultinational environment /b. /li /ulpbr/ppRequired Qualifications: /pulliAround b3 years of experience in Regulatory Affairs /b within the pharmaceutical industry. /liliStrong knowledge of bCMC documentation and regulatory dossier preparation /b (Modules 1 3). /liliExperience with blifecycle management /b, including bvariations and renewals /b. /liliFamiliarity with bASMF and QoS documentation /b. /liliExperience supporting bmulti-region regulatory submissions /b, preferably across bEMEA and/or LATAM /b. /liliAbility to work effectively in binternational and cross-functional teams /b. /liliStrong organizational skills and attention to detail. /liliFluency in bEnglish and Spanish /b; /li /ulpbr/ppbNext Steps /b /ppUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. /ppIf there's a positive match, a technical interview with the Hiring Manager will be arranged. /ppIn the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. /ppAlternatively, if the outcome is negative, we will contact you to halt the recruitment process. /ppbr/ppbWorking at PQE Group /b /ppAs a member of the PQE team, you will be part of a bchallenging, multicultural company that values collaboration and innovation /b. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. /ppIf you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. /ppApply now and take the first step towards an amazing future with us. /p