Description
Regulatory Manager - OperationsLocation: 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, labelling, 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 Suliman Maroof at or call me on .