Assessor/-in (m/w/d) Qualitätsbewertung
Hybrid
Core
Evaluate quality data for blood products and gene therapy drugs during European and national approval processes.
Role type
Senior regulatory assessor (biomedicines)
Builds
Regulatory assessments and guidelines for novel biomedicines
Domain
Life Sciences / Regulatory Affairs / Gene Therapy
Deliverable
dashboards & analysis
Required skills
Analyze experimental data, Protein biochemistry, Virology, Cell or molecular biology, Gene and/or cell therapy knowledge
Preferred skills
PhD, Experience in drug development and regulation
Technologies
Microsoft Office, Databases
Responsibilities
Evaluate quality data for biomedicines, Consult drug developers and manufacturers, Participate in manufacturing site inspections, Contribute to regulatory guideline development, Represent the institute in national and international committees