Drug Regulatory Affairs Manager 80-100%

vor 5 Stunden


Basel, Schweiz Gi Group SA Vollzeit

 

Für das Unternehmen unseres Kunden in Basel suchen wir einen

 

Drug Regulatory Affairs Manager 80-100%

 

Tasks:

 

  • Selbständige Erstellung und Pflege von Zulassungs- und Registrierungsdossiers für unsere Arzneimittel, mit Fokus auf präklinische (Toxikologie und Sicherheit) und klinische Dokumentation
  • Erarbeitung der entsprechenden Dokumentationen im Rahmen von Neuzulassungen, Verlängerungen, Änderungsanträgen oder anderen behördlichen Anforderungen
  • Mitarbeit bei der Packmitteltexterstellung und Stellvertretung der Informationsbeauftragten
  • Kommunikation mit internen und externen internationalen Partnern
  • Konstruktive und engagierte Mitarbeit in nationalen und internationalen Pharmaprojekten

 

Required:

 

  • Erfolgreich abgeschlossenes Studium der Pharmazie, Chemie, Lebensmittelchemie, Biologie oder vergleichbare Ausbildung
  • Idealerweise Erfahrung im Bereich Drug Regulatory Affairs
  • Kenntnisse über toxikologische und klinische Anforderungen von Arzneimitteln, sowie Erfahrung im industriellen pharmazeutischen Umfeld von Vorteil
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift, Drittsprache wünschenswert
  • Zuverlässige, genaue Arbeitsweise auch unter Zeitdruck, sowie offene und transparente Kommunikationsfähigkeiten
  • Freude an der Arbeit in internationalen Teams und am Austausch mit Fachkräften insbesondere aus Klinik und Toxikologie
  • Versierter Umgang mit MS-Office, sowie Kenntnisse zu eCTD und Datenbankmanagement-Systemen erwünscht
  • Interesse an den Werten und der Kultur der Weleda, insbesondere an komplementären- und Phyto-Arzneimitteln, Nachhaltigkeit und sozialer Verantwortung


 



Branche: Pharma-Industrie

Funktion: Qualitätsprüfung

Anstellungsart: Festanstellung

Karrierestufe: Angestellte/r




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