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Regulatory Affairs Manager for Phytopharmaceuticals and Homeopathic Products (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Natural
Projektbeschreibung
241112/8
IHRE AUFGABEN:
-Preparation and writing of registration dossiers (part 2 and 3 / CMC)
-Saving of regulatory compliance
-To check the documents for completeness and plausibility
-Independent preparation of the Quality Overall Summary (Module 2.3)
-Preparation of professional answering letters foreign authorities
-To support internal regulatory advice for product development and quality changes (change control)
IHRE QUALIFIKATIONEN:
-University degree in natural sciences (pharmacy, chemistry, biology, medicine, etc.) or equivalent professional experiences
-Profound knowledge of international and national pharmaceutical legislation and quality documentation
-Experience with phytopharmaceuticals and homeopathic products
-Experience in creating and dealing with eCTD
-Very good knowledge of English and German
WEITERE QUALIFIKATIONEN:
Regulatory affairs associate
Projektdetails
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Einsatzort:
Berlin, Deutschland
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Projektbeginn:
asap
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Projektdauer:
3 MM++
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges