Description
The role entails:- Handling global Regulatory Affairs maintenance work on licensed products in close collaboration with regulatory counterparts in affiliate companies
- Plan, manage and execute regulatory activities on licensed products such as submission of variations, renewals, line extensions, responses to Authority requests, Marketing Authorisation Applications in further countries
- Serve as the Regulatory Affairs representative in the Safety Management Team where appropriate and other internal teams
- Plan, manage and execute regulatory activities on product(s) such as subsmission of variations, renewals, line extensions, responses to Authority requests, Marketing Authorisation Applications in further countries
- Lead staff and teams in the development of alternative regulatory strategies/ risk- benefit analyses for pharmaceutical compounds in all phases of clinical development
- Drive submissions through the approval procedure (National, MRP, DCP, CP)
They are offering between £60-70 an hour for the right candidate. Please do let me know if this might be of interest to you, or alternatively, if you know anyone who might be interested, please do let me know.
To find out more about Real please visit www.realstaffing.com