Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, we’re joined by Steve Gens, founder of Gens and Associates, to talk about where AI is really heading in regulatory, beyond the hype cycle.
The Implementation Point
Steve Gens has spent years benchmarking how regulatory teams adopt technology. His read right now: regulatory teams are moving from experimentation to implementation. His pulse data points to mid-2026 through mid-2027 as the first major implementation wave for AI in regulatory. Mid-tier and large multinational companies are advancing real use cases in health authority correspondence, regulatory intelligence, content and document generation.
One of the most concrete examples from the conversation:
Steve paints a picture of a regulatory team receiving a question from a health authority. In the old world, finding out whether a similar question had been asked before, identifying how the company responded, and shaping a new response could have taken weeks. In the new world, an AI agent can review health authority correspondence and dossiers, identify similar questions across markets, and suggest a response as part of a faster, AI-assisted workflow.
Steve’s framework for thinking about it: phases. Phase one (now through 2027) is individual document generation: CSRs, safety reports, CMC documents. Phase two, three to four years out, is dossier automation. The companies that build skills and test real use cases in phase one are the ones positioned for phase two when it arrives.
On the workforce question, Steve shared a line he said he’d heard and found profound:
“People aren’t going to lose their jobs to AI. If they don’t use AI, that’s the reason they’re going to lose their job.”
The harder question, one the episode gets into, is what happens to the junior roles that have always been how people learn the regulatory business, when AI starts handling the work those roles were built around.
Steve has watched the internet, cloud computing, and eCTD each reshape this industry. He sees AI as the start of another major shift, and says 2026 and 2027 are when the conversation moves from pilots to results. This episode is a good place to calibrate where you actually stand.
Steve’s top resources:
- Do you have a business case for AI? Answer a few questions to find out
- Know what to ask vendors: Download the AI Vendor Checklist
- Simplify agency correspondence with AI: Watch AI in action
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