Artificial intelligence (AI) is increasingly being introduced into pharmaceutical development, including in the preparation of regulatory documentation. Despite growing investment, however, its adoption remains uneven. Evidence suggests that the principal barriers are not technological but human and organisational. Factors such as professional identity, psychological safety, governance, and trust influence whether AI tools become meaningfully integrated into everyday workflows. In regulated environments such as pharmaceutical development, where regula tory decisions depend on clear reasoning and traceable evidence, introducing AI-assisted writing requires careful consideration of accountability, workflow design, and professional roles. Successful adoption, therefore, depends not only on the capabilities of AI systems but also on the conditions under which teams can use them confidently and responsibly. Understanding these organisational and behavioural factors will be critical if AI is to deliver genuine value in regulatory medical writing rather than remaining limited to isolated pilot applications.