EU CTR Regulatory Lead - Clinical Trials Specialist

IQVIA Inc

Oeiras

On-site

EUR 40,000 - 70,000

Full time

7 days ago

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Job summary

IQVIA in Portugal is seeking a Regulatory Affairs professional to join our Biotech Regulatory Affairs team, supporting clinical research projects across Europe. You will provide regulatory expertise and hands-on support throughout clinical development, with a focus on EU CTR submissions, working within a global project-based team on drug development programs including chemical entities and biologics.

This role offers ownership of regulatory activities within assigned projects and opportunities

Qualifications

Bachelor’s degree in a scientific field or equivalent.
At least 3 years of Regulatory Affairs or related experience.
Hands-on EU CTR submission experience.
Good understanding of European clinical trial regulatory requirements and GCP.
Experience reviewing clinical and regulatory documentation.

Responsibilities

Take regulatory responsibility for assigned clinical research projects, providing regulatory guidance and operational support.
Independently prepare and complete EU CTR submissions on time.
Interpret and apply regulations, guidelines and regulatory agency requirements.
Review protocols, reports and other clinical/regulatory documents for compliance.
Support regulatory authority interactions, communications and submissions.
Compile and manage regulatory documentation for projects.