IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas
Job Summary
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
As Regulatory & Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
You will prepare submission documents and submit to regulatory bodies.
Matching Summary
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
Skills & Requirements
Must-have
EU CTR experience for Germany and Austria
Local language proficiency
National regulatory requirements knowledge
Site Activation activities
Regulatory submission document preparation
Nice-to-have
Collaborative culture
Agile structure
Deep therapeutic expertise
Sponsor-facing role
Key Requirements
1-3 years clinical research experience
EUCTR and CTIS submission procedures
Feasibility and Country Informed Consent adaptation for DACH