Euro Convergence: The future calls for 'bionic' regulatory professionals

BRUSSELS – As the regulatory field becomes more complex, experts said companies are looking for regulatory talent who can use artificial intelligence (AI) to work more efficiently and make better decisions. One expert said that AI won’t replace human workers, but “bionic regulatory professionals” will use the technology to minimize certain tasks so they can focus more on planning and management.

During a panel session at the RAPS Euro Convergence 2025, Rebecca Lumsden, head of regulatory science and policy in the EU at Sanofi, urged regulatory professionals to embrace artificial intelligence (AI) and evolve professionally with the technology.

“This is the only time when five different generations are currently in the workforce, and this is also presenting and creating some challenges,” said Lumsden. “What this means is, we’re in a time of rapid skill evolution.

“It's not enough to come into a role and learn a core set of skills and know that those skills will take you through to the end of your career,” she added. “You always have to be open to change, growth and development.”

Lumsden said that everyone in the industry is struggling to find talented professionals who understand the complexities of the technologically evolving landscape, and companies are eager to hold on to workers who have the skills to meet the demands of the new reality. She said that means they must identify, develop, and retain talented workers with the right skills who thrive in navigating an increasingly complex regulatory environment.

“We have heard so much over the last few days about the need to have more guidance, to have more clarity, but actually, sometimes, working in the grey space is where regulatory professionals excel,” said Lumsden.

Lumsden said that Sanofi wants to become the first pharmaceutical company to use AI at scale and that it already uses the technology to make everyday decisions. More specifically, she noted that the company has adopted different kinds of AI from expert-level AI to solve complex problems, generative AI to streamline processes and improve productivity, and “snackable” AI that helps workers make better day-to-day decisions.

Sanofi also has a couple of fundamental pillars that guide their use of AI, according to Lumsden, including using the technology responsibly for everyone. She emphasized that everyone at the company is trained in using AI responsibly.

"The goal is not to use AI for everything," she said. "The goal is to stay focused on AI, unlocking an area of significant potential for us to introduce efficiencies or to address business needs.

Lumsden characterized the future of regulatory affairs as an evolution in which regulatory professionals will need to use AI to make their work more efficient. She noted that the role of a regulatory professional is highly complex and can entail addressing issues such as regulatory strategy development, risk management, regulatory intelligence, documentation management, and more. Furthermore, she said that regulatory affairs professionals today can embody more than such roles and play a broader part in the health ecosystem than ever before. She also noted that while regulatory professionals were previously seen as barriers to the scientists trying to get products to market, today they are seen as enablers who can explain the regulatory complexities and should be part of the development planning.

To manage the evolving roles that regulatory professionals are being asked to take on, Lumsden said they need to adapt to the technology and use it to make their jobs easier and more efficient. She added that the technology can help automate and simplify tasks that add less value to regulatory professionals' work and allow them to focus more on tasks such as strategic development.

“The time is now for the bionic regulatory affairs professional across the whole community,” said Lumsden.

“The goal is using AI, the human working with the machine, not the machine replacing the human, that we can lift some of that burden and allow us to move to a future based on a digital ecosystem,” she added.

Euro Convergence: The future calls for 'bionic' regulatory professionals

Related topics

Recommended content

Welcome to the new RAPS Digital Experience