Description
Regulatory Submissions Manager - OperationsLocation: Berkshire, London
Package: up to £60,000 circa + excellent benefits
Having recently acquired a new business my client is seeking a Regulatory Submissions Manager who is looking for a challenging career's 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 eCTD
Nees, and 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 our Senior Regulatory Consultant with your C.V directly to n.hopkins(a)realstaffing.com or call on .