Regulatory Affairs Manager Role:
Support one or more products from a regional regulatory perspective.
Work with cross-functional teams, including those in Development, Medical, Commercial, and Value and Access.
Achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions.
Ensure that the company acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products and to ensure timely regulatory compliance with above approvals.

Your Background:
Relevant experience with regulatory activities in the EU region including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
Good knowledge of and experience in regional regulatory environment in relevant product area and development stage of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
Experience with EU and national legislation and regulations relating to medicinal products
Cultural awareness and sensitivity to achieve results across both regional country and International borders.

Apply:
For more information, or to apply for this Regulatory Affairs Manager please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 53148.