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Senior Regulatory Affairs Manager

vor 4 Monaten

Munich, Deutschland Constares GmbH Vollzeit

Unser Kunde ist ein führendes Pharmaunternehmen, das sich der Erforschung und Entwicklung von innovativen Therapien und Medikamenten in der Virologie, Onkologie und im Bereich entzündlichen Erkrankungen verschrieben hat.


Zur Unterstützung der Aktivitäten des Regulatory Affairs Teams in Zusammenarbeit mit lokalen Regulierungsbehörden und anderen Interessengruppen suchen wir Sie in der Rolle als


Senior Regulatory Affairs Manager (m/w/d)


Ihr Aufgabengebiet:

  • Eigenverantwortliches Management der regulatorischen Aktivitäten für zugewiesene Produkte und Themen
  • Management aller Aktivitäten, die erforderlich sind, um eine konforme Kennzeichnung im Land zu gewährleisten und rechtzeitige Aktualisierungen durchzuführen
  • Überprüfung der Übersetzungen der deutschen Anhänge im Zusammenhang mit Änderungen zentral genehmigter Zulassungen (MAs)
  • Prüfung und Genehmigung von Werbematerial
  • Überwachung des Beschwerdemanagements
  • Leitung der Einreichung von Zulassungsanträgen bei lokalen Gesundheitsbehörden (HA)
  • Unterstützung bei der Sicherstellung der Einhaltung nationaler Gesetze und Vorschriften
  • Bereitstellung von strategischem Input für lokale Markenteams und andere interne Arbeitsgruppen
  • Aktive Teilnahme an speziellen Ad-hoc-Projekten zur kontinuierlichen Verbesserung und Weiterentwicklung der Regulatory Affairs


Ihre Fähigkeiten und Erfahrungen:

  • Hochschulabschluss oder vergleichbare Ausbildung, vorzugsweise in Naturwissenschaften, Medizin oder Pharmazie
  • Mindestens 5 Jahre Erfahrung in einer Affiliate RA-Rolle sowie Kenntnisse der regulatorischen Anforderungen in der Pharma-/Biotech-Industrie einschließlich ICH-Anforderungen und -Vorschriften
  • Kenntnisse des AMG und anderer Gesetze wie AMWHV und HWG
  • Fähigkeit, unter hohem Zeitdruck an mehreren Projekten zu arbeiten
  • Hervorragende mündliche und schriftliche Kommunikationsfähigkeit in Deutsch und Englisch


Weitere Details:

  • Start zum nächstmöglichen Zeitpunkt
  • Hybrides Arbeitsmodell in Vollzeit
  • 30 Urlaubstage im Jahr
  • Attraktives Gehaltspaket


Haben wir Ihr Interesse geweckt? Dann freuen wir uns auf Ihre Bewerbung