Regulatory Affairs Specialist, IQVIA Biotech
Core
Regulatory Affairs professional supporting clinical research projects across Europe, focusing on EU Clinical Trials Regulation (EU CTR) submissions for drug development programs.
Role type
Regulatory Affairs Specialist
Builds
Regulatory submissions and documentation for clinical trials
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
EU CTR submission management, regulatory compliance interpretation, clinical documentation review, cross-functional collaboration, analytical skills
Preferred skills
North America regulatory experience, biologics experience, CRO/pharma industry background, medical-device regulatory knowledge
Technologies
None stated
Responsibilities
Prepare and complete EU CTR submissions independently, review protocols and clinical documentation for compliance, support regulatory authority interactions, provide regulatory guidance to project teams, manage regulatory documentation
Seniority
Mid-level, hands-on IC