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Regulatory Affairs Manager (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Marketing, Support

Projektbeschreibung

REFERENZNUMMER:

339938/11

IHRE AUFGABEN:

-Be responsible for leading some of the EU regulatory activities, including operational and strategic activities in drug development, centralised procedure pre- and post-marketing phases
-Preparation and submission for regulatory approval of clinical trial authorisation applications
-Support regulatory strategy and communication
-Coordination of clinical study report activities as required
-Labelling activities
-Coordination of periodic reports or other update to regulatory documents as required, e.g. PSUR, RMP, IB, CCDS
-Preparation of Orphan Drug annual reports for EU and US

IHRE QUALIFIKATIONEN:

-Mandatory previous experience in a pharmaceutical company or a CRO
-Minimum Bachelor degree in life science
-A solid experience in a similar role, responsible for EU regulatory affairs
-Demonstrated experience in regulatory activities in centralised procedure
-Experience in clinical trial applications
-Previous experience in orphan drugs will be highly appreciated
-Knowledge of EU regulatory affairs guidelines and regulations
-Fluency in English, both written and oral

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 MM+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland