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Regulatory Affairs Associate

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support

Projektbeschreibung

This role, under the direction of an EURL or supervisor, will assist in the creation and maintenance of regulatory strategies, submissions and other documents.

Your key responsibilities will be:

- Provide and maintain CTA documentation (e.g. IMPD, substantial amendments, etc) in collaboration with EU Regulatory Lead
- Create and maintain product regulatory history documents through IMR/RISE and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- Ensure compliance via timely submissions to regulatory agencies
-Coordinate collection of functional documents in support of regulatory applications
- As appropriate, participate in GRT to support execution of regulatory strategy
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies

You will also require:

* Strong communication skills - both oral and written
* Organizational skills & developing regulatory project management skills
* Ability to work with some autonomy within restricted activities

If this role is of interest and you would like to discuss it in more detail then please contact Peter Duvall at Real Staffing on 02077587322To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland