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Regulatory Affairs Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
-Write part 2 and 3 of the regulatory dossier BLA for a NDA submission
-Support the process validation team in oder to put together the documentation of the process validation (manufacturing site)
-Ensure that all documentation is in compliance with the FDA guidlines
-Experienced in writing regulatory dossiers
-Know how of the production of biologics
-Perfect commande in English, French is a big plus
-Know how about hemophilia/bleeding disorder is an advantage
Weitere Qualifikationen: Regulatory affairs associate, Regulatory affairs manager
-Support the process validation team in oder to put together the documentation of the process validation (manufacturing site)
-Ensure that all documentation is in compliance with the FDA guidlines
-Experienced in writing regulatory dossiers
-Know how of the production of biologics
-Perfect commande in English, French is a big plus
-Know how about hemophilia/bleeding disorder is an advantage
Weitere Qualifikationen: Regulatory affairs associate, Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges