Regulatory Affairs Manager (m/w/d) QRD
Core
Independent regulatory review and evaluation of European product information (SmPC) focusing on Quality Review of Documents (QRD) aspects, language checks, and terminology consistency for vaccines and biomedicines.
Role type
Regulatory Affairs Manager (QRD)
Builds
Regulatory compliant product information and documentation for vaccines and biomedicines
Domain
Life Sciences / Regulatory Affairs / Immunology
Required skills
Regulatory requirements knowledge, QRD guidelines, Centralized authorization procedures, Immunology, Medical/pharmacological terminology, MS Office, Database management
Preferred skills
PhD, Pharmaceutical industry experience, English communication
Technologies
MS Office, Databases, Digital documentation systems
Responsibilities
Review and evaluate European SmPCs for QRD aspects, Conduct language checks and linguistic quality assurance, Verify user/readability testing implementations, Check substance names against SPOR databases, Support QRD process development, Coordinate with EMA and internal/external stakeholders
Seniority
Mid-Senior, Independent contributor
