EU CTR Regulatory Specialist (Drug & Biologics)

IQVIA; Warszawa; On-site; PLN 139,000 - 257,000; Full time

Job summary

IQVIA, a leading global provider of clinical research services, seeks a Regulatory Affairs professional to support clinical programs across Europe. You will lead EU CTR submissions, interpret regulatory requirements, and guide cross-functional teams to ensure compliant, timely deliverables for research programs including chemical entities and biologics.

The role emphasizes independent submission management, strong regulatory knowledge across EU jurisdictions, and collaboration with international

Qualifications

• Bachelor's degree in a scientific field or equivalent experience.
• At least 3 years of Regulatory Affairs or clinical research experience.
• Hands-on EU CTR submission experience and independent management.
• Solid understanding of European clinical trial regulations and GCP.
• Experience reviewing clinical and regulatory documentation.
• Strong analytical skills and attention to detail.
• Excellent written and verbal communication.

Responsibilities

• Take regulatory responsibility for assigned clinical research projects.
• Prepare and complete EU CTR submissions.
• Interpret and apply regulations and regulatory agency requirements.
• Review protocols and reports for regulatory compliance.
• Support regulatory authority interactions and submissions.
• Provide regulatory input to cross-functional project teams.

Skills

Regulatory affairs

EU CTR submissions

Cross-functional collaboration

Attention to detail

Regulatory communication

Education

Bachelor's degree

Job description

IQVIA, a leading global provider of clinical research services, seeks a Regulatory Affairs professional to support clinical programs across Europe. You will lead EU CTR submissions, interpret regulatory requirements, and guide cross-functional teams to ensure compliant, timely deliverables for research programs including chemical entities and biologics.

The role emphasizes independent submission management, strong regulatory knowledge across EU jurisdictions, and collaboration with international