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Drug Regulatory Affairs Project Manager (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Projektbeschreibung

REFERENZNUMMER:

364766/11

IHRE AUFGABEN:

-Provide regulatory strategy for the international countries (outside the following countries: US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
-Maintain regulatory knowledge for international countries (new registrations, variations & renewals of marketed products)
-Liaise and coordinate all documentation, submissions and activities with affiliates for NCE dossiers and life cycle of marketed products
-Respond to health authority questions in coordination with Global DRA Project Leader and project teams
-Coordinate the archiving of submitted registration dossiers and other relevant health authority communication
-Evaluate and review the regulatory activities of potential and existing business partners' contracts and quotations

IHRE QUALIFIKATIONEN:

-Degree in life science and profound experience in International Drug Regulatory Affairs
-Knowledge and experience of global regulatory processes
-Ability to work in multicultural environment
-Excellent communication, interpersonal, negotiation and problem solving skills Capable of working independently as well as effective team player
-Accuracy and good project management skills
-Excellent command of spoken and written English, other languages are of advantage

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager

Projektdetails

  • Einsatzort:

    Basel-Country, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    12 MM+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland