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Senior CMC Regulatory Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Design
Projektbeschreibung
-Support different global CMC regulatory teams
-Write CMC sections of clinical (IND/CTA) and marketing applications (NDA/MAA)
-Interact with representatives from technical functions in order to assemble CMC documentation for global submissions
-Review submissions, collect information from CMC teams and reviewers
-Lead review discussions and modify documents
-Life Sciences background
-Experience with CMC regulatory affairs, formulation development or analyitcal development
-Know-how of IND/CTA and NDA/MAA submissions
-Experience in Quality by Design
-Perfect English, written and spoken
Weitere Qualifikationen: Regulatory affairs manager
-Write CMC sections of clinical (IND/CTA) and marketing applications (NDA/MAA)
-Interact with representatives from technical functions in order to assemble CMC documentation for global submissions
-Review submissions, collect information from CMC teams and reviewers
-Lead review discussions and modify documents
-Life Sciences background
-Experience with CMC regulatory affairs, formulation development or analyitcal development
-Know-how of IND/CTA and NDA/MAA submissions
-Experience in Quality by Design
-Perfect English, written and spoken
Weitere Qualifikationen: Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland