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Senior Manager Of Regulatory Affairs

Eingestellt von Real Staffing Group aus Frankfurt am Main

Projektbeschreibung

An exciting biotechnology company is seeking a Senior Manager of Regulatory Affairs to help their team with both domestic and international submissions. With products on the market, the Senior Manager will assist in submissions in OUS markets and domestic PMA submissions.

- Develop regulatory strategies for class III biologic based medical device
- Represent regulatory affairs team on product development teams
- Assist in preparation and submission of original PMA
- Prepare and manage various international submissions with international health agencies (FDA, MDD, Health Canada, etc.)
- Review labeling and promotional material
- BS in Life Sciences preferred
- Experience with PMA, BLA, or NDA submissions
- Knowledge of QSR and GMP requirements
- Excellent project management skills
- Strong communication skills

To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Oakland, California, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland