Regulatory Systems Leader role at Pierre Fabre driving evolution and performance of regulatory platforms. Overseeing strategy implementation and ensuring user support.
TK
Hybrid Regulatory Affairs Manager – Generika
Posted 3 months ago
About the role
- Regulatory Affairs Manager overseeing medication approval processes at a leading pharmaceutical firm. Collaborating with regulatory authorities and managing documentation for approvals and renewals.
Responsibilities
- Eigenverantwortliche Betreuung der Verfahren in der Arzneimittelzulassung
- Die Zulassungsdokumentation im eCTD-Format und deren Einreichung bei den Behörden
- Life-Cycle-Management (Renewals, Variations)
- Direkter Kontakt mit Zulassungsbehörden sowie Ansprechpartner für interne und externe RA Fragestellungen
- Betreuung und Optimierung der regulatorischen Informations-Datenbank
- Erstellen und Prüfen von Produktinformationstexten
Requirements
- Ein abgeschlossenes Studium (z.B. pharmazeutisch/naturwissenschaftlich)
- Berufserfahrung im Bereich Regulatory Affairs
- Sehr gute Sprachkenntnisse in Deutsch sowie Englisch
- Analytisches Denken, schnelle Auffassungsgabe und gute Organisationsfähigkeit
- Teamgeist und Kommunikationsstärke
Benefits
- Flexible Arbeitsbedingungen (inkl. Homeoffice)
- 30 Tage Urlaub + 3 Brückentage
- Ein sympathischen Team
- Attraktives Gehalt & umfangreiche Sozialleistungen (u.a. Alters- und Gesundheitsvorsorge…)
- Hervorragende Weiterbildungsangebote
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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