Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
TK
Hybrid Regulatory Affairs Manager – Biosimilars
Posted 2 months ago
About the role
- Regulatory Affairs Manager focusing on biosimilars for global biopharmaceutical firm. Ensuring compliance with regulatory requirements across various markets.
Responsibilities
- Umsetzung globaler regulatorischer Vorgaben auf nationaler Ebene in enger Abstimmung mit internationalen RA-Teams
- Erstellung, Prüfung und Pflege zulassungsrelevanter Dokumente
- Pflege von externen Portalen (z. B. Arzneimittellisten und Informationsservices)
- Begleitung von Artwork-Änderungen sowie Implementierung regulatorischer Updates über den gesamten Produktlebenszyklus
- Weiterbilden zu regulatorischen Entwicklungen und Kommunikation relevanter Informationen an interne Schnittstellen
- Sicherstellung einer nachvollziehbaren Dokumentation im Rahmen des bestehenden DMS
Requirements
- Erfolgreich abgeschlossenes Studium (Naturwissenschaften, Pharmazie, oder vergleichbar)
- Berufserfahrung im Bereich Regulatory Affairs für Humanarzneimittel
- Idealerweise Erfahrung mit zentralen Zulassungsverfahren und internationalen Schnittstellen
- Verhandlungssichere Deutschkenntnisse (C1) sowie gute Englischkenntnisse.
- Strukturierte und sorgfältige Arbeitsweise.
Benefits
- Attraktive Vergütung und umfangreiche Zusatzleistungen (z.B. Altersvorsorge)
- Flexible Arbeitszeiten sowie 2 Tage Homeoffice p. Woche
- Umfangreiche Weiterbildungs- und Entwicklungsmöglichkeiten
- Jobticket, JobRad, uvm.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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