What Top Regulatory Teams Are Doing Differently in 2025

If you are from the life sciences industry or you’ve been following the regulatory world, you know it’s never been busier—or more unpredictable. New regulations and guidelines seem to drop every week, and the push for global launches is relentless. As a result of which, today’s most successful Regulatory Affairs teams are shaping strategy and driving business value by bringing innovation in everything they do.

So, what exactly are these top teams doing to stay ahead in 2025? Let’s take a closer look:

1. Getting Smart with Regulatory Intelligence

Gone are the days of scattered spreadsheets and long email chains. Leading RA teams now rely on robust regulatory intelligence platforms that do the heavy lifting:

• Aggregating updates from thousands of health authorities, with changes mapped directly to impacted products.
• Collaborative workspaces where R&D, Clinical, Quality, and other teams can actually work together—commenting, assigning tasks, and tracking progress in real time.
• Predictive insights that help leaders prioritize, whether it’s forecasting inspection risk or deciding which post-approval variations need attention.

IBM Consulting recently found that generative AI is reducing drafting timelines for clinical modules by up to 75%. But don’t worry—human experts are still in the loop, making sure speed never trumps compliance.

2. Bringing Regulatory to the Table from Day One

The smartest companies don’t treat regulatory as an afterthought. Instead, they invite Regulatory affairs experts into product discussions right from the start. This early involvement pays off:

• Fewer protocol amendments—up to 40% fewer, according to Deloitte.
• Better relationships with regulators, who appreciate seeing risk mitigation built into the plan.
• Alignment with business goals so compliance decisions actually support commercial success.

3. Automating the Boring Tasks

Automation is everywhere, but the best teams use it wisely. They let AI handle repetitive, rules-based tasks—like literature surveillance or first-draft medical writing or regulatory research—so their people can focus on strategy. But they also:

• Invest in AI literacy for everyone—Johnson & Johnson’s 56,000-person training initiative is a great example.
• Invest in tools and platforms that are built for regulatory.

4. Staying Ahead with Proactive Intelligence

RA teams have become intelligence engines. The best ones:

• Map new guidance onto internal SOPs and templates before anyone even asks.
• Use predictive analytics to flag compliance risks early – at Freyr Global Regulatory Intelligence, we are developing advanced capabilities to make these insights readily accessible through our intuitive, interactive dashboards.

5. Mastering the Global-Local Balancing Act

With ICH expanding guidelines (like M14 and M12), top RA teams:

• Monitor harmonization in real time and update global dossiers proactively. Freya.Intelligence is built to help you keep track of regulations from over 200+ markets across the globe on your fingertips.
• Partner with local experts to navigate tricky regional requirements, whether in LATAM, MENA, or APAC.
• Use content management systems that generate country-specific documents on the fly or tools that help you go through complex documents in seconds.

This blend of global frameworks and local know-how speeds up approvals and minimizes last-minute headaches.

6. Investing in People Not Just Techology

At the end of the day, it’s people who make the difference. Leading organizations:

• Offer tiered training, from digital bootcamps to specialized AI pathways.
• Encourage cross-domain rotations so regulatory professionals get hands-on experience in clinical, PV, manufacturing, and commercial teams.
• Build feedback loops and knowledge-sharing sessions to keep improving.

It is always the well-trained teams that are better at spotting risks and adapting to change.

7. Weaving in Sustainability and Holistic Risk Governance

ESG seems to be the highlight of the past few years. That’s true for the world of regulatory as well. Regulatory submissions now routinely include ESG data and supply chain transparency. The best teams:

• Build sustainability into submission strategies, especially in regions like the EU and Canada.
• Take active roles in product recall and pharmacovigilance governance.
• Develop dynamic, risk-based SOPs that evolve with the business.

Conclusion

As we move through 2025, regulatory affairs is going to be a catalyst for innovation. By investing in regulatory intelligence, smart automation, early engagement, global harmonization, and continuous learning, top RA teams can drive faster approvals and real commercial impact.

Is your team ready to lead the next wave? Check out our Regulatory Intelligence Platform, Freya.Intelligence, for real-time regulatory tracking, keeping up with guidance and updates, and automated workflows. Position your organization at the forefront of regulatory change.

Try it for free for 14-days!