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Regulatory Affairs Manager - Operations

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Client, Support

Projektbeschreibung

Regulatory Affairs Manager - Operations - Global Consultancy

Location: Berkshire,London

Description

Regulatory Affairs Manager - Perm
Berkshire

Having recently acquired a new business my client is seeking a Regulatory Affairs Manager who is looking for a challenging career- this is an employer that enables you to make a real difference.

Package: £55,000 - 59,000

My client offers an extensive benefits package which includes 30 days vacation per year, a car allowance, variable bonus scheme and private medical insurance.

The Role
To support Regulatory Operations in the generation of electronic submissions
Conduct regulatory reviews of technical summaries, quality, non clinical and clinical study reports

Assist with the filings and approval processes for MAA products within all types of European Regulatory Procedures.

Assist with the assembly of Common Technical Document (CTD) and electronic CTD filings
Assist with providing regulatory expertise on of MA life cycle management (variations, renewals, labeling, and line extensions

Experience:
Significant experience in the pharmaceutical industry
Knowledge and experience with MAA
Project management skills

Practical experience with electronic submissions, preferably eCTD
Knowledge of the European Regulatory and EU/ICH Guidelines
Supervisory skills

If you are keen to hear more information contact Natalie Hopkins at or call me on 02077587311.To find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland