Regulatory Affairs Professional

We are seeking a Regulatory Affairs professional to join our IQVIA Biotech Regulatory Affairs team, supporting clinical research projects across Europe.

In this role, you will provide regulatory expertise and hands-on support throughout clinical development, with a particular focus on EU Clinical Trials Regulation (EU CTR) submissions. You will work as part of a global, project-based team supporting primarily drug development programs, including chemical entities and biologics.

This is a great opportunity for someone who already has practical EU CTR submission experience and is ready to take ownership of regulatory activities within assigned projects.

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 primarily drug development programs, including chemical entities and biologics.
• Contribute to broader Regulatory Affairs activities and cross-functional initiatives as required.

Requirements

• Bachelor’s degree, ideally in a scientific or related discipline, or an equivalent combination of education and relevant experience.
• At least 3 years of relevant professional experience within Regulatory Affairs, clinical research or a closely related area.
• Hands-on EU CTR submission experience, with the ability to manage and complete submissions independently.
• Good understanding of European clinical trial regulatory requirements and Good Clinical Practice.
• Experience reviewing and working with clinical and regulatory documentation.
• Strong analytical skills and the ability to interpret complex regulatory information.
• Excellent written and verbal communication skills.
• Strong attention to detail and the ability to work effectively within cross-functional and international project teams.

Nice to Have

• Regulatory experience outside Europe, for example North America.
• Experience working with biologics.
• Previous CRO and/or pharmaceutical/biotech industry experience.
• Knowledge of medical-device regulatory requirements.

The potential base pay range for this role, when annualized, is 138 600,00 zł - 257 400,00 zł.