EU CTR Regulatory Specialist

IQVIA Inc; Województwo mazowieckie; On-site; PLN 139,000 - 257,000; Full time

Job summary

IQVIA Inc. is seeking a Regulatory Affairs professional to join the Biotech Regulatory Affairs team, supporting European clinical research programs. You will provide regulatory expertise and hands-on support across EU CTR submissions and related activities.

The role focuses on drug development programs, including small molecules and biologics, with ownership of submissions and collaboration with cross-functional, international project teams.

Qualifications

• 3+ years in Regulatory Affairs or clinical research.
• Hands-on EU CTR submission experience.
• Good understanding of European clinical trial regulations.

Responsibilities

• Lead regulatory activities for assigned clinical research projects.
• Prepare EU CTR submissions independently.
• Ensure regulatory requirements and timelines are met.
• Review protocols and regulatory documents for compliance.
• Support regulatory authority interactions and submissions.
• Maintain regulatory documentation for projects.
• Provide guidance to cross-functional teams.

Skills

Regulatory affairs

EU CTR submissions

Clinical research

Cross-functional teamwork

Education

Bachelor’s degree in a scientific field

Job description

IQVIA Inc. is seeking a Regulatory Affairs professional to join the Biotech Regulatory Affairs team, supporting European clinical research programs. You will provide regulatory expertise and hands-on support across EU CTR submissions and related activities.

The role focuses on drug development programs, including small molecules and biologics, with ownership of submissions and collaboration with cross-functional, international project teams.