Description
Regulatory Affairs Operations Specialist / Senior Specialist - Operations - Global ConsultancyLocation: Berkshire,London
Description
Permanent Role
Location: You can commute from London, Reading, Hugh Wycombe, Berkshire
Having recently acquired a new business my client is seeking a Regulatory Affairs Operations Specialist who is looking for a challenging career- this is an employer that enables you to make a real difference.
Package: £47,500 + Excellent benefits package
My client offers an extensive benefits package which includes 32 days holiday 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
Project Management
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 on this role or any other publishing or Regulatory roles contact Natalie Hopkins at or call .
To find out more about Real please visit www.realstaffing.com