Regulatory Affairs Manager
vor 4 Wochen
Regulatory Affairs Manager
Wir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Kunden in der Region Zürich unterstützen kann.
Aufgaben
- Leitung des Regulatory Affairs Teams und Entwicklung von Mitarbeiter:innen
- Entwicklung und Umsetzung von globalen regulatorischen Strategien
- Verantwortung für die Einreichung von Zulassungsanträgen bei nationalen und internationalen Behörden
- Überwachung und Bewertung von Gesetzesänderungen und regulatorischen Standards
- Koordination von Audits und Inspektionen durch Zulassungsbehörden
- Zusammenarbeit mit internen Abteilungen, externen Beratern und Partnern
- Sicherstellung der Einhaltung von Qualitätsstandards und regulatorischen Anforderungen
Anforderungen
- Abgeschlossenes Studium im Bereich Pharmazie, Chemie, Biologie oder vergleichbare Qualifikation
- Mehrjährige Führungserfahrung im Bereich Regulatory Affairs, vorzugsweise in der pharmazeutischen Industrie
- Fundierte Kenntnisse der nationalen und internationalen regulatorischen Anforderungen
- Erfahrung in der Zusammenarbeit mit Zulassungsbehörden und in der Durchführung von Audits
- Kommunikationsstärke und Verhandlungsgeschick
- Teamorientierte Arbeitsweise und Eigeninitiative
- Gute Deutsch- und Englischkenntnisse in Wort und Schrift
Wir wertschätzen Vielfalt und begrüßen daher alle Bewerbungen – unabhängig von Geschlecht, sozialer Herkunft, Religion/Weltanschauung, Alter und Identität.
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