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Drug Regulatory Affairs Project Leader (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
REFERENZNUMMER:
234466/11
IHRE AUFGABEN:
-Provide EU regulatory strategic input
-Liaise with EMA as primary regulatory contact and with EU NCA
-Ensure appropriate communication of correspondence from EMA/EU NCA to colleagues, teams and management in accordance with agreed communication routes
-Ensure EU labeling (Anneses and associated documents) remains in compliance with CCDS and EU/ICH regulations
IHRE QUALIFIKATIONEN:
-Life-Sciences degree
-Profound experience of regulatory affairs
-Good knowledge of regulatory aspects at various stages of development from entry-into man to post approval activities
-Know how of clinical trial methodology and statistics
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
234466/11
IHRE AUFGABEN:
-Provide EU regulatory strategic input
-Liaise with EMA as primary regulatory contact and with EU NCA
-Ensure appropriate communication of correspondence from EMA/EU NCA to colleagues, teams and management in accordance with agreed communication routes
-Ensure EU labeling (Anneses and associated documents) remains in compliance with CCDS and EU/ICH regulations
IHRE QUALIFIKATIONEN:
-Life-Sciences degree
-Profound experience of regulatory affairs
-Good knowledge of regulatory aspects at various stages of development from entry-into man to post approval activities
-Know how of clinical trial methodology and statistics
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland