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Global Regulatory Affairs Project Support Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
256715/1
IHRE AUFGABEN:
-Manage the regulatory submission process through to approval, including management and coordination of the preparation of all regulatory documentation at different regulatory milestones
-Manage of the regulatory agency interactions, document preparation, coordinate rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist)
-Contribute to regulatory strategies for projects (under supervision of the Regulatory Strategist)
-Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labelling) , including CTAs
IHRE QUALIFIKATIONEN:
-Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
-Experience in CTA requirements WW
-Experience in preparation and submission through to authorization of a full submission/or large variation/supplement in at least one ICH region
-Experience with maintenance of regulatory authorizations in at least one region
-Experience with regulatory agency interactions and preparation of documentation to support interactions
-Experience with supporting a project with development activities in at least two regions
-Knowledge of international regulatory affairs (supported by said experience)
-Knowledge of special consideration opportunities WW
-profound industry experience and regulatory experience
-eCTDs experience
-English business fluent
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
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Einsatzort:
Hesseneck, Deutschland
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Projektbeginn:
asap
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Projektdauer:
12 MM
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges