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CMC Regulatory Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
261610/11
IHRE AUFGABEN:
-Support the global CMC regulatory teams in writing CMC sections, support in renewals and answers to deficiency letters
-Support and facilitate reviews of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
-Support Technical Regulatory Leader to maintain system and databases
IHRE QUALIFIKATIONEN:
-University degree in chemistry, pharmacy, life sciences or equivalent
-Experience in pharmaceutical CMC regulatory affairs, formulation development, quality, or analytical development is required; experience in post-approval submission is advantageous
-Fluent English skils, both written and verbal
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
261610/11
IHRE AUFGABEN:
-Support the global CMC regulatory teams in writing CMC sections, support in renewals and answers to deficiency letters
-Support and facilitate reviews of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
-Support Technical Regulatory Leader to maintain system and databases
IHRE QUALIFIKATIONEN:
-University degree in chemistry, pharmacy, life sciences or equivalent
-Experience in pharmaceutical CMC regulatory affairs, formulation development, quality, or analytical development is required; experience in post-approval submission is advantageous
-Fluent English skils, both written and verbal
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges