Núria Romero Carol

WORK HISTORY

EDUCATION

SKILLS

ABOUT NÚRIA ROMERO CAROL

Regulatory Affairs professional with more than 25 years of experience supporting pharmaceutical, biotech and medtech companies across the full product lifecycle, from development and registration to post-authorization and lifecycle management.Since 2016, I have been leading Asphalion as CEO, combining a strong regulatory and scientific background with a practical business and strategic approach. My experience covers Regulatory Affairs consulting, operations, business development and international expansion, working closely with EMA, FDA and multiple national health authorities.I am particularly focused on building long-term, trusted partnerships with clients, helping them navigate complex regulatory frameworks in a pragmatic and efficient way, while supporting sustainable growth and innovation. I value clear communication, realistic solutions and empowered teams that deliver tangible impact.Throughout my career, I have been involved in high-level scientific and technical interactions with health authorities and in the design and execution of complex regulatory strategies across multiple markets and therapeutic areas, including innovative and advanced therapies.I am increasingly interested in the role of digitalization and AI in transforming regulatory processes and decision-making, and I actively promote innovation as a driver of efficiency, quality and value within our industry.Always open to meaningful conversations, new challenges and collaborations at the intersection of science, strategy and people.