Skip to content

Submissions Manager - Global Pharma

This job is no longer available

Recruiter
Real Staffing
Posted
28 March 2013
Closes
25 April 2013
Ref
RE-12458469
Contact
Natalie Hopkins
Sector
Contract Type
Hours
Salary
£55000 - £56000 per annum + Excellent Package

Further information

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

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

To find out more about Real please visit www.realstaffing.com

Real Staffing

Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services.