EU CTR Regulatory Specialist: Lead Submissions & Compliance

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

Job summary

IQVIA Inc leads a Biotech Regulatory Affairs team supporting clinical research across Europe, with a focus on EU CTR submissions for drug development programs including chemical entities and biologics. You will own regulatory activities within assigned projects and collaborate with a global team to ensure regulatory compliance and timely submissions.

Ideal candidates have a bachelor’s degree in a scientific field and at least 3 years of Regulatory Affairs experience, plus hands‑on EU CTR

Qualifications

• Bachelor’s degree in a scientific or related discipline; equivalent experience considered.

Responsibilities

• Take regulatory responsibility for assigned clinical research projects, providing regulatory guidance and operational support to project teams.
• Independently prepare and complete EU CTR submissions, ensuring regulatory requirements and timelines are met.
• Interpret and apply relevant regulations, guidelines and regulatory agency requirements.
• Review protocols, reports and other clinical and scientific documentation for regulatory compliance.
• Support regulatory authority interactions, communications and submissions.
• Compile, maintain and manage regulatory documentation required for assigned clinical research projects.
• Provide regulatory input and guidance to cross‑functional project teams.
• Support drug development programs, including chemical entities and biologics.
• Contribute to broader Regulatory Affairs activities and cross‑functional initiatives as required.

Skills

EU CTR submission experience

Regulatory understanding

Analytical skills

Written & verbal communication

Attention to detail

Cross-functional teamwork

Education

Bachelor’s degree in scientific discipline

Job description

IQVIA Inc leads a Biotech Regulatory Affairs team supporting clinical research across Europe, with a focus on EU CTR submissions for drug development programs including chemical entities and biologics. You will own regulatory activities within assigned projects and collaborate with a global team to ensure regulatory compliance and timely submissions.

Ideal candidates have a bachelor’s degree in a scientific field and at least 3 years of Regulatory Affairs experience, plus hands‑on EU CTR