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Associate Director Regulatory Affairs
vor 4 Wochen
Unser Kunde ist ein etabliertes, international tätiges Pharmaunternehmen mit Fokus in den Bereichen Gynäkologie, Neurologie und Rare Diseases.
Das Büro liegt im Herzen Münchens mit guter Anbindung.
Ihre Aufgaben:
- Koordination und Verwaltung von Zulassungsanträgen für nationale Behörden
- Überwachung der Einhaltung pharmazeutischer Vorschriften und behördlicher Genehmigungen
- Sicherstellung der Pharmakovigilanz und Meldung von Sicherheitsproblemen
- Leitung von Audits und Inspektionen, sowie Bearbeitung von Feststellungen
- Beratung der Unternehmensleitung und Teamführung für regulatorische Angelegenheiten
- Leitung und Entwicklung eines Teams für regulatorische Angelegenheiten
Stellenanforderungen:
- Abschluss an einer Hochschule in Pharmazie, Pharmakologie oder einem verwandten Bereich
- Breite Erfahrung in regulatorischen Angelegenheiten und Einhaltungsvorgängen in der Pharmaindustrie
- Erfahrung mit der Verwaltung von Arzneimittelsicherheitssystemen und Pharmakovigilanz
- Fundiertes Verständnis globaler regulatorischer Anforderungen und Standards zur Qualitätssicherung
- Verhandlungssichere Deutschkenntnisse sowie fließende Englischkenntnisse
Benefits:
- Unbefristeter Arbeitsvertrag mit ansprechendem Leistungspaket
- Betriebliche Altersvorsorge
- 30 Tage Urlaub im Jahr
- Erstattung des MVG-Tickets
Sie haben Interesse an unserer offenen Vakanz? Dann bewerben Sie sich ganz einfach direkt hier und wir kommen zeitnah auf Sie zu
Wir freuen uns, Sie kennenzulernen
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