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CMC Regulatory Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Marketing
Projektbeschreibung
REFERENZNUMMER:
362876/11
IHRE AUFGABEN:
-Support global CMC regulatory teams by writing CMC sections of post-approval marketing applications
-Establish renewals and answers to deficiency letters
-Perform regulatory assessment of change controls and discrepancies
-Support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
-Support shareholders (mainly Quality) in term of CMC regulatory oversight
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 with post-approval submission is advantageous
-Detail oriented with excellent interpersonal skills
-English-language speaking and written skills are required
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
362876/11
IHRE AUFGABEN:
-Support global CMC regulatory teams by writing CMC sections of post-approval marketing applications
-Establish renewals and answers to deficiency letters
-Perform regulatory assessment of change controls and discrepancies
-Support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents
-Support shareholders (mainly Quality) in term of CMC regulatory oversight
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 with post-approval submission is advantageous
-Detail oriented with excellent interpersonal skills
-English-language speaking and written skills are required
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