Regulatory affairs should be involved from the early stages of a drug development programme, not just before submission. Early involvement helps align clinical, CMC, quality, and scientific strategies with regulatory requirements. The role of regulatory affairs in drug development includes regulatory strategy, compliance, health authority communication, and submission planning. Early regulatory input can help identify risks, avoid costly rework, and reduce development delays. In regulatory affairs in drug development, continuous collaboration with clinical, quality, and scientific teams is essential for a successful development pathway. Molkem supports this integrated approach by helping organisations address regulatory requirements effectively. Conclusion The ideal time to involve regulatory affairs is as early as possible. Strong regulatory affairs and drug development collaboration help minimise regulatory risks and support a smoother path toward product approval.