Vakante Jobangebote finden Sie unter Projekte.
Regulatory Affairs Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
- Preparation of regulatory documentation for submissions to regulatory agencies
- Manage and prepare Clinical Trial Applications worldwide until approval of particular studies
- Compile dossiers for lifecycle management and maintenance activities of marketed products (mainly for Europe, Canada and Australia)
- Profound experience in Regulatory Affairs
- Experience with NCE/NBE (New Chemical Entities / New Biological Entities), one with device experience
- Knowledge of European regulatory pathways (CP, DCP/MRP, national procedures)
- Experience in regulatory maintenance activities for authorizations in Europe and major international countries
- Experience in preparation and submission of Clinical Trial Applications (worldwide)
- Excellent spoken and written English
Weitere Qualifikationen: Regulatory affairs manager, , Drug regulatory affairs manager
Projektdetails
-
Einsatzort:
Hesseneck, Deutschland
-
Projektbeginn:
asap
-
Projektdauer:
12 MM
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
Sonstiges
Hays
-
Straße:
Willy-Brandt-Platz 1-3
-
Ort:
68161 Mannheim, Universitätsstadt, Deutschland