Regulatory Affairs Specialist - EU CTR Submissions

About the role

IQVIA Biotech is looking for a Regulatory Affairs Specialist to join its Regulatory Affairs team in Lisbon, supporting clinical research projects across Europe. The role provides regulatory expertise and hands-on support throughout clinical development, with a focus on EU Clinical Trials Regulation (EU CTR) submissions, within a global, project-based team mainly covering drug development programs of chemical entities and biologics.

Key responsibilities

• Take regulatory responsibility for assigned clinical research projects, giving regulatory guidance and operational support to project teams.
• Independently prepare and complete EU CTR submissions, meeting regulatory requirements and timelines.
• Interpret and apply 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 for assigned projects.
• Provide regulatory input and guidance to cross-functional project teams and contribute to broader Regulatory Affairs activities.

Required profile

• Bachelor's degree, ideally in a scientific or related discipline, or an equivalent combination of education and experience.
• At least 3 years of relevant experience in Regulatory Affairs, clinical research or a closely related area.
• Nice to have: regulatory experience outside Europe (e.g. North America), experience with biologics, previous CRO or pharma/biotech experience, knowledge of medical-device regulations.

Required skills

• Hands-on EU CTR submission experience, able to manage and complete submissions independently.
• Good understanding of European clinical trial regulatory requirements and Good Clinical Practice.
• Experience reviewing clinical and regulatory documentation.
• Strong analytical skills, excellent written and verbal communication, strong attention to detail, and ability to work in cross-functional, international teams.