As regulatory frameworks evolve and the pace of change accelerates, pharmaceutical companies face mounting pressure to keep up with shifting expectations. The FDA’s recent changes to guidance formats and the increasing complexity of global requirements have made it clear that traditional approaches to regulatory affairs are no longer sufficient. In this environment, artificial intelligence is emerging as a critical enabler of smarter, faster, and more integrated regulatory operations.

The rise of the integrated regulatory ecosystem

An integrated regulatory ecosystem combines AI-powered tools with expert services to help regulatory professionals stay ahead of global changes. These ecosystems do more than deliver alerts—they provide actionable insights tailored to specific portfolios. Tools like IQVIA’s Regulatory Intelligence Assistant are designed to surface and contextualize regulatory updates across dozens of markets simultaneously, helping teams understand not just what has changed, but how it affects their work.

This shift from reactive to proactive regulatory intelligence is closing a critical gap. Regulatory professionals now have access to real-time insights that support faster decision-making and more strategic planning.

Augmenting, not replacing, the regulatory professional

While early conversations around AI in life sciences often centered on job displacement, the narrative is shifting. AI is increasingly viewed as a tool for augmentation rather than replacement. Tasks such as identifying health authority trends or auto-generating draft submission documents are time-consuming and often low-value. By automating these functions, AI allows experienced professionals to focus on interpretation, planning, and engagement.

For newer professionals entering the field, AI is becoming a standard part of the job. The expectation is no longer whether AI will be used, but how effectively it can be integrated into daily workflows. Solution providers have a responsibility to ensure these tools are transparent, validated, and designed to elevate—not replace—regulatory judgment.

Comparing regulations across borders

Global regulatory affairs teams have long relied on manual comparisons to plan and sequence submissions. These processes were slow, siloed, and labor-intensive. AI is now transforming this aspect of regulatory work by automating comparisons and detecting emerging patterns across markets.

With AI, teams can:

• Access comparative insights in real time
• Push updates directly into workflows
• Scale regulatory intelligence across regions

This level of automation was previously unattainable and is now enabling more proactive and continuous global regulatory planning.

Addressing cybersecurity and data integrity

As AI becomes more embedded in regulatory processes, concerns around cybersecurity, data privacy, and algorithmic bias are growing. These issues, while often discussed together, require distinct governance models.

IQVIA’s approach includes:

• A global, integrated information security framework with continuous monitoring and incident response
• Privacy-by-design protocols with strict access controls
• Oversight of algorithmic bias through ethics boards and federated modeling techniques

The key to mitigating risk is maintaining a human-in-the-loop approach. AI tools must pass quality checks and be guided by expert oversight to ensure fairness, accuracy, and security.

Meeting the demands of modern development pipelines

One of the biggest challenges facing regulatory teams today is aligning operations with the speed and complexity of modern drug development. Submissions are more frequent, updates are constant, and global requirements continue to evolve in non-harmonized ways. Many systems in place were not designed to handle this level of complexity.

Success now depends on intentional integration, not just digitization. This means embedding intelligent tools into existing systems and workflows to support real-world regulatory work. Whether preparing lifecycle management updates or coordinating major dossiers, the focus is on connected insight and coordinated execution.

Looking ahead: practical AI applications for regulatory affairs

At industry events like DIA, thought leaders are emphasizing the practical applications of AI in regulatory affairs. The goal is not to hand over control to automation, but to enable professionals with tools that support their expertise. Technologies like machine learning, natural language processing, and robotic process automation are being used to augment, not overhaul, regulatory processes.

The future of global regulatory affairs lies in the thoughtful integration of AI tools that support strategic decision-making, enhance efficiency, and maintain the integrity of regulatory judgment. As the industry continues to evolve, regulatory professionals equipped with the right tools will be better positioned to navigate complexity and drive innovation.