Dr. Anke Arnold-Tugulu

I am Leading the Respiratory and Transplant TAs in the European Regulatory Affairs department at CSL Behring. I currently have 3 direct reports and 5 people in my team.

As a Manager in Regulatory Affairs I am responsible for the marketed drug Actemra in the European Union and the rest of the world (RoW). My tasks include maintainance activities regarding the existing marketing authorization, as well as leading crossfunctional teams and filing of new indications as well as any kind of communication with the competent authorities like EMA.

Regulatory Lead of early development projects in the area of Anti-infectives and Cardiovascular diseases, responsibility for international paediatric development of a marketed product (Tracleer®).

Module 1 preparation of a national marketing authorization application Coordination of a readability test of Patient Leaflet Project responsibility for an early phase project in the anti-infective area Authoring IMPDs Leading Health Authority interaction during CTA approval process