Remote EU Regulatory Affairs Senior Manager (CTA/Submissions)

Theradex Systems, Inc. in the UK/Europe is seeking a Contract Regulatory Affairs Manager/Senior Manager to lead EU regulatory submissions, incl. CTA and amendments, and to liaise with EU regulators.

This is a 6-month T&M contract, remote option available for based in the UK or Sweden. The role requires substantial EU regulatory experience, knowledge of ICH-GCP, DSURs, USMs, and input into regulatory strategies.