(Junior) Chemiker Regulatory Affairs
Vor 2 Tagen
Die Dr. E. Graeub AG ist ein traditionsreiches Schweizer Pharmaunternehmen und führend auf dem Gebiet der Tiermedizin. Das Produktportfolio umfasst Pharmazeutika, Biologika und Futtermittel. Am Firmensitz in Bern werden eigene Produkte entwickelt, produziert und vertrieben. Ergänzt wird das Spektrum durch einlizensierte Produkte internationaler Firmen. Als Teil der Livisto-Gruppe ist dieDr. E. Graeub AG auch in der EU und weltweit bestens vernetzt. Mit dem anstehenden Umbau der Produktion wird der Standort Schweiz auch zukünftig ein wichtiger Baustein in der Gruppe bleiben. Arbeitsort: Bern.
Aufgaben
- Erstellen chemisch-pharmazeutischer Zulassungs-Dossiers für die Schweiz und die EU (NtA, VNeeS)
- Einreichen neuer Zulassungsanträge für Pharmazeutika in der Schweiz und der EU (inkl. eSubmission, CESP)
- Verwalten des bestehenden Portfolios, Aktualisieren und Erweitern bestehender Zulassungen
- Koordinieren des Change Control-Prozesses und Begleiten des Änderungsmanagements
- Optimieren analytischer Methoden von bestehenden Zulassungen und Ansprechpartner gegenüber Behörden und Partnern bei analytischen Fragestellungen
- Unterstützen bei der Übersetzung von Fachinformationen und Beipackzetteln auf Französisch.
- Unterstützen bei Qualifizierungen und Validierungen
Qualifikation
- Abgeschlossenes Chemie
- oder Pharmaziestudium (Uni, FH)
- Sie besitzen gutes Know-how in der Analytik, insbesondere HPLC
- Idealerweise bereits erste Erfahrungen in der Registrierung / Regulatory Affairs.
- Äusserst exakte und strukturierte Arbeitsweise
- Sehr gute Französisch
- und Deutschkenntnisse
**Benefits**:
- Sie arbeiten in einem kleinen, familiären Team mit 6 Personen und bekommen eine intensive Einführung in das Themengebiet.
- Sie können Verantwortung übernehmen und sich fachlich wie persönlich weiterentwickeln.
- Sie arbeiten in einem stabilen Traditionsunternehmen mit guten Zukunftsaussichten.
Art der Stelle: Vollzeit
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