Regulatory Affairs Specialist

vor 5 Monaten

Schwalbach am Taunus, Deutschland Tempo-Team Personaldienstleistungen GmbH Vollzeit

Schwalbach am Taunus 55.000€ - 60.000€ Vollzeit Gesundheit und Sozialwesen

Hey, du bist auf Jobsuche? Das trifft sich super, denn wir suchen Menschen, die zu uns passen, und dein neuer Job als **Regulatory Affairs Associate** in **Schwalbach am Taunus** ist nur noch wenige Klicks entfernt. Wir freuen uns auf deine Bewerbung Du bist genau richtig, wie du bist Sei einfach du selbst. Wir wollen niemanden verändern und freuen uns auf jede Bewerbung

**Was wir anbieten**:

- Selbstständiges Arbeiten
- Im Unternehmen wachsen
- Chance auf unbefristeten Vertrag
- Moderne Arbeitsplätze

**Was wirst du tun**:

- Unterstützung der Teammitglieder von bei Aktivitäten im Zusammenhang mit der Koordinierung von Life-Cycle-Management-Aktivitäten
- Mitarbeit bei Aktivitäten im Zusammenhang mit Rollouts (Erweiterungen auf White Space), Variationen, Verlängerungen
- Beantwortung von Anfragen von Gesundheitsbehörden und anderen Sicherheits
- oder Qualitätsberichten (PQRs oder PSURs)
- Unterstützung der Mitarbeiter bei der Sicherstellung der Wartung und Aktualisierung des Regulatory-Information-Management-Systems
- Mitarbeit bei allen erforderlichen Aktivitäten im Zusammenhang mit GTRAQ-Verfahren und -Systemen
- Erarbeitung von regulatorischen Anforderungschecklisten und ihren jeweiligen Ordnern und deren Abläufen
- Abwicklung und Bearbeitung aller administrativen Aufgaben und Anforderungen (Erklärungen, Vollmachten etc.)
- Ausarbeitung von Berichten über Key Performance Indicators (KPI) in Bezug auf einige RA-Aktivitäten
- Erarbeitung von regulatorische Bewertungen oder Vorabbewertungen
- Beratung der Organisation über potenzielle regulatorische Risiken bei normalen täglichen Aktivitäten
- Arbeit einem Coach zur Durchführung der erforderlichen Abhilfe
- oder Minderungsmaßnahmen
- Pünktliche Durchführung von Analysen und Aufgaben
- Information von Manager und Tagescoach über den Fortschritt

**Was bringst du mit**:

- Abgeschlossenes Studium im naturwissenschaftlichen Bereich
- Berufserfahrung und Kenntnisse in den oben genannten Tätigkeiten ist erforderlich
- Gute MS-Office-Kenntnisse
- Sehr gute Englischkenntnisse

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