Regulatory Affairs Specialist, IQVIA Biotech

We are looking for 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.

What you will be doing

• 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.

What we are looking for

Essential:

• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is 138 600,00 zł - 257 400,00 zł. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.