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Global Regulatory Affairs Project Support Manager (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Support

Projektbeschreibung

REFERENZNUMMER:

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

  • Einsatzort:

    Hesseneck, Deutschland

  • Projektbeginn:

    asap

  • Projektdauer:

    12 MM

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland