• Develop and lead global Regulatory CMC strategies for investigational and commercial small molecule and ASO products, aligned with development, manufacturing, and commercialization objectives. • Serve as the Regulatory CMC subject matter expert, providing strategic guidance on regulatory risks, timelines, and mitigation plans across the product lifecycle. • Ensure strong cross-functional partnership and alignment with Quality, Analytical, Development, Supply Chain and Commercial Manufacturing teams to support integrated CMC planning and execution. • Author and oversee preparation, review, and submission of CMC sections for INDs, IMPDs, NDAs, and post-approval supplements, ensuring consistency, quality, and regulatory compliance. • Lead and support CMC-related interactions with global health authorities (e.g., FDA, EMA), including meeting strategy, briefing materials, and responses to regulatory inquiries. • Provide regulatory oversight for clinical and commercial manufacturing, including process validation, control strategies, stability programs, and supply continuity. • Lead CMC regulatory strategies for post-approval changes, comparability assessments, technology transfers, and manufacturing site changes. • Build and manage internal Regulatory CMC capabilities and oversee external consultants, CMOs, and regulatory vendors, contributing to scalable processes and governance.