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Regulatory Affairs Manager ( Pharma)

Eingestellt von Real Staffing Group aus Frankfurt am Main

Projektbeschreibung

An exciting and challenging permanent opportunity has opened up for a Regulatory Affairs Manager with diversified regulatory experience and a strong focus on domestic and global pharmaceutical strategy. The role will be responsible for managing regulatory activities in both foreign and domestic markets. The right candidate should be able to hit the ground running, and have both preclinical and clinical RA strategy. RESPONSIBILITIES: -Preparation and coordination of regulatory submissions for marketed products -Coordinate INDs, NDAs, renewals, labelling updates and variations. -Liaises with company affiliates and third parties to coordinate a variety of activities -Communicate regulatory strategy to project teams for assigned products -Liaises with regulatory, manufacturing and other parties as appropriate -Lead regulatory team meetings -Plan, prepare, and track, submissions to regulatory agencies. SKILLS REQUIRED: * Bachelor's degree in a relevant discipline *Proven significant experience in Regulatory Affairs. *Experience in the submission of regulatory documentation *Direct experience working with Regulatory Authorities *Excellent organization skills and ability to multi-task *Ability independently manage workload

To find out more about Real please visit www.realstaffing.com [1]

Links:
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[1] http://www.realstaffing.com

Projektdetails

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland