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Senior Regulatory CMC Manager

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Marketing

Projektbeschreibung

The candidate will be responsible for the ehe strategy and execution of the preparation of CMC components for EU and Emerging Market filings from marketing authorisation to post-approval supplements, renewals and responses to agency questions.

The daily activities will heavily involve:

- Preparation of CMC components for EU and EM filings from marketing authorisation to post-approval supplements, renewals and responses to questions
- Considers how EU and EM regional issues impact regulatory strategy for proposed CMC filings e.g. product timelines, supply continuity, impact on overall timelines
- Contributes to CMC product teams: Reports status of activities and projects to teams and department
-Provide expertise and guidance on teams for interdepartmental and cross-functional teams including, process improvement standards development and metrics
- Direct experience with EU Emerging (IE) market applications - MAAs and variations

They are looking to interview candidates over the next week with the first stage being a short telephone interview.

If this role could be of interest to you then please contact Peter Duvall at Real Pharma on 02077587322To find out more about Real please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Marketing/Vertrieb

  • Skills:

    marketing

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland