Job Opportunities API

Regulatory Affairs Specialist (w/m/d) beim Exeltis Schwesterunternehmen Xiromed Regulatory Affairs Specialist (w/m/d) beim Exeltis Schwesterunternehmen Xiromed Online seit 15.07.2025 das ist ein Text Xiromed /Medical Valley ist in 10 Ländern aktiv und Teil der INSUD Pharma Group. Wir sind ein pharmazeutisches Unternehmen mit Hauptsitz in Höllviken Südschweden, das vor allem auf dem nord- und westeuropäischen Markt präsent ist. Xiromed vertreibt qualitativ hochwertige generische Medikamente in Deutschland. Unsere 120 Medikamente werden hauptsächlich an unseren spanischen Produktionsstandorten hergestellt. Unser Produktportfolio besteht aus einer Vielzahl von verschreibungspflichtigen Medikamenten mit dem Schwerpunkt Herz-Kreislauf, Urologie, Muskel-Skelettsystem und Antiinfektiva. Deine Aufgaben: Eigenständige Betreuung von Zulassungsanträgen und Lifecycle-Management Koordination der Einreichungen bis zur Genehmigung Organisation und Pflege regulatorischer Dokumente Zusammenarbeit mit Behörden und internen Teams bei Produktzulassungen Sicherstellung der Einhaltung aller Auflagen für den Marktzugang Entwicklung und Pflege von Artworks in digitalen Tools Dein Profil: Hochschulabschluss in Gesundheitswissenschaften, Pharmazie, Chemie, Biologie oder vergleichbar 1–3 Jahre Erfahrung in der pharmazeutischen Regulierung, ideal im Generika-Bereich Sehr gute Englischkenntnisse, Spanischkenntnisse sind von Vorteil Kenntnisse in eCTD, CMC und EU-Regulatorik Das bieten wir: Ein attraktives Gehalt mit leistungsabhängigem Bonus Umfassendes Onboarding und ein tolles Arbeitsklima Flexible Arbeitszeiten und die Möglichkeit zum Mobile Office 30 Tage Urlaub und Überstundenregelung Attraktive Sozialleistungen und Weiterbildungsmöglichkeiten Kurze Entscheidungswege in einem internationalen Umfeld Ein motiviertes Team, das dich unterstützt und etwas bewirken möchte Hast Du Lust, wirklich etwas zu bewegen? Dann freuen wir uns auf Deine Bewerbung! 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