**PRINCIPAL DUTIES AND RESPONSIBILITIES:**

+ Compilation and update of drug dossiers with focus on the clinical part in close alignment with the therapy field director
+ Provide answers to authorities on registration related medical/pharmacological questions in close alignment with the director of the respective therapy field and with drug regulatory
+ Support of drug development projects
+ Participation in audits: support of therapy field leader with respect to therapy field relevant documents
+ Supportive function in risk management, in particular concerning medico-regulatory topics: Provide support in the development, maintenance and updating of documents related to risk management deliverables
+ Participation in cross-functional teams for medical-regulatory aspects
+ Authorship of assessments concerning product development issues, in analysis of clinical data and in defining the medical evidence needed for driving or improving product development processe...