In this exciting, newly created role you will be handling international Regulatory Affairs maintenance work on licensed product(s) in close collaboration with local affiliate companies in multiple countries around the world.

You will play a lead role in planning, managing and executing regulatory activities on your assigned products in the countries where they are approved.

This will include submission of variations, renewals, line extensions, responses to authority requests and Marketing Authorisation applications. In addition to experience of regulatory affairs you will be possess excellent project management and communication skills with the ability to engage effectively across different geographies, regulatory systems and organisations.

You will plan, manage and execute regulatory activities on product(s) such as submission of variations, renewals, line extensions, responses to Authority requests, Marketing Authorisation Applications in further countries. Also drive submissions through the approval procedure (MRP, DCP, CP) in the EU.

This is a fantastic opportunity to join a growing organisation at an exciting time of change and growth and to gain regulatory experience in a truly international environment.

If you are highly motivated, committed and looking for your next career move, call me without delay for a further discussion, I look forward to hearing from you.

Michelle Jackson (Regulatory Affairs Consultant) + 44 1273 727 930 alternately you can email michelle@stelfoxuk.com

With over 7 years experience in recruitment and outsourcing Michelle specialises in Regulatory Affairs for the pharmaceutical industry.
Stelfox - 13 months ago