Global Regulatory Operating Model For Pharma Leaders

This episode explores how pharmaceutical organisations can effectively structure regulatory roles across global, regional, and local markets. Based on the DDReg guide to global regulatory operating models, the discussion highlights the strategy of "controlled decentralization"—maintaining global consistency for core scientific positions while ensuring local authority ownership where jurisdiction-specific knowledge is critical.Key topics covered include: The five-layer operational structure: Defining decision rights across enterprise regulatory governance, product strategy, regional translation, local execution, and regulatory operations. Cross-functional coordination: Clarifying accountabilities between regulatory affairs, clinical development, CMC/quality, pharmacovigilance, and supply chain functions. Modern data standards & technology: How eCTD v4.0, ISO IDMP master data standards, Regulatory Information Management (RIM) systems, and AI in 2026 are reshaping regulatory workflows and data governance