Drug Regulatory Affairs Manager 80-100%
vor 5 Stunden
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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