Submissions Manager - Global Pharma

City of London
£55000 - £56000 per annum + Excellent Package
28 Mar 2013
25 Apr 2013
Natalie Hopkins
Full Time

Regulatory Submissions Manager - Operations

Location: Berkshire,London

Package: £52,000 - £55,000 circa + excellent benefits

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

My client offers an extensive benefits package which includes 30 days holiday per year, variable bonus scheme and private medical insurance as well as paid overtime .

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

Project management / project lead

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

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 n.hopkins(a) or call me on 02077587311.

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