EU Regulatory Affairs Specialist - EUCTR Submissions Lead

IQVIA Inc; Lisboa; On-site; EUR 40,000 - 65,000; Full time

Job summary

IQVIA Inc. is seeking a Regulatory Affairs professional to join our Biotech Regulatory Affairs team in Lisbon, Portugal. You will support EUCTR submissions and provide regulatory guidance across European clinical research programs, including chemical entities and biologics.

You will work with a global project-based team to ensure timely, compliant regulatory deliverables and drive cross-functional initiatives within assigned projects.

Qualifications

• Bachelor’s degree in a scientific field or equivalent experience.
• 3+ years in Regulatory Affairs or closely related area.
• Hands-on EUCTR submission experience and ability to manage submissions independently.
• Strong understanding of European clinical trial regulations and GCP.
• Experience reviewing clinical/regulatory documentation and cross-functional collaboration.

Responsibilities

• Take regulatory responsibility for assigned clinical research projects and provide guidance to project teams.
• Independently prepare and complete EUCTR submissions on time.
• Interpret and apply regulations, guidelines, and agency requirements.
• Review protocols and reports for regulatory compliance.
• Support regulatory authority interactions, communications, and submissions.
• Maintain and manage regulatory documentation for projects.
• Provide regulatory input to cross-functional teams.

Skills

Regulatory Affairs

EUCTR submissions

Clinical research

Documentation review

Education

Bachelor’s degree in science

Tools

Regulatory submission software

Job description

IQVIA Inc. is seeking a Regulatory Affairs professional to join our Biotech Regulatory Affairs team in Lisbon, Portugal. You will support EUCTR submissions and provide regulatory guidance across European clinical research programs, including chemical entities and biologics.

You will work with a global project-based team to ensure timely, compliant regulatory deliverables and drive cross-functional initiatives within assigned projects.