Regulatory Affairs teams will not be divided into those using AI and those not using AI. They will be divided into those that can defend AI, and those that cannot.
AI is moving into submissions, regulatory intelligence, safety surveillance and document generation. But speed is not what regulators trust. Explainability is.
A dangerous misconception can be observed in the industry: AI is still too often treated as an IT project, but it is becoming a regulatory issue.
The uncomfortable truth: some organizations are adopting generative AI faster than they are implementing governance.
A dossier produced faster has little value if nobody can explain the source data, validation, human oversight or accountability behind the output.
Regulatory Affairs may become the most important AI governance function in pharma.
Not because RA slows innovation. Because RA understands evidence, traceability, risk and trust.
The question is no longer whether pharma should use AI. The question is whether pharma can defend it during review, audit or inspection.
Are RA professionals being prepared to lead AI governance, or to review technologies they do not fully understand?
If your organization wants AI-enabled regulatory processes without compromising trust, quality or inspection readiness, contact Starodub to start the conversation at info@starodub.nl or visit our website at www.Starodub.nl.
