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CMC Regulatory Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Marketing
Projektbeschreibung
REFERENZNUMMER:
316980/11
IHRE AUFGABEN:
-Support global CMC regulatory teams by helping to write CMC sections of post-approval marketing applications, assist in the renewal of and answering to deficiency letters
-Facilitate and support review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
-Assist the Technical Regulatory Leader in maintaining the 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
-Experience in post-approval submission is advantageous
-Attention to detail with excellent interpersonal skills
-Good English language speaking and writing skills
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
316980/11
IHRE AUFGABEN:
-Support global CMC regulatory teams by helping to write CMC sections of post-approval marketing applications, assist in the renewal of and answering to deficiency letters
-Facilitate and support review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
-Assist the Technical Regulatory Leader in maintaining the 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
-Experience in post-approval submission is advantageous
-Attention to detail with excellent interpersonal skills
-Good English language speaking and writing skills
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges
Hays
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Straße:
Willy-Brandt-Platz 1-3
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Ort:
68161 Mannheim, Universitätsstadt, Deutschland