Regulatory agencies worldwide acknowledge the growing importance of artificial intelligence (AI) to enhance efficiency in drug development, manufacturing, and post-market oversight, yet clear frameworks for AI use in biomanufacturing remain nascent. Recent analyses highlight the need for adaptable, agile regulatory approaches capable of managing rapidly evolving AI technologies such as machine learning and generative AI. Emphasis is placed on capacity building, continuous training, and the establishment of specialized AI teams within agencies to balance innovation with patient safety and to lead oversight in the AI era. This evolving landscape presents both opportunities and challenges for regulators and industry alike.