Regulatory Interpretation: Demonstrated capability interpreting and operationalizing US FDA CFRs (Parts 58, 210, 211, 312, 820, 1271, 600), ICH guidelines, EMA directives, and PMDA requirements using a risk-based, fit-for-purpose strategy. Oversee quality risk management (QRM), deviation investigations, CAPA, and Change Control workflows across cross-functional R&D, Clinical, and Manufacturing teams to resolve operational non-conformances and safeguard program timelines.