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Regulatory Affairs Assistant

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support

Projektbeschreibung

Regulatory Affairs Assistant

The Regulatory Affairs Assistant provides project specific administrative support to projects at all stages of the drug development cycle.

This is an ideal position for somebody with a pharmaceutical background looking to move in to the Regulatory Affairs department.

Responsibilities for this role include:

- Under the direction of a senior member of the department, coordinate & manage compilation of regulatory & ethics committee submissions throughout EMEA, Asia Pacific and Latin America regions
- Manage third party vendors such as printing, courier and translation service providers
- Assist with the coordination of translation of submission documents such as protocols, synopsis, ICF and labels
- Ensure publishing and perform administrative QC of all submissions in a timely manner
- Manage and track global submissions, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools
- Liaise with CRAs, study site coordinators and regulatory representatives and effectively communicate status of submissions to the Regulatory Affairs Lead
- Ensure regulatory study files are well maintained and audit ready at all times

The role is with a global CRO based in either London or the East Midlands, offering a £30k starting salary.To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland