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Regulatory Affairs Professional (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
317240/3
IHRE AUFGABEN:
-To be the EU RA representative in global development teams and provide regulatory guidance and strategy for assigned projects
-To plan, lead and manage regulatory submissions during development and life cycle management (including maintenance), e.g. CTAs and amendments, MAAs and variations, to European and other assigned authorities
-To act as the primary regulatory contact person for authorities
IHRE QUALIFIKATIONEN:
-Regulatory Affairs professional with experience in the pharmaceutical industry and in-depth experience in global regulatory affairs with focus on EU requirements
-Therapeutic area experience in oncology
-Strong understanding of all areas of global drug development and respective regulatory requirements from early to late stage development
-Preparation and handling of scientific advice, orphan drug and PIP procedures and other regulatory submissions
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
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Einsatzort:
Bavaria, Deutschland
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Projektbeginn:
asap
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Projektdauer:
6 MM
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
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