• Provide regulatory strategy input for small molecule and biologic products • Support regulatory leads in developing contingency plans for CMC-related scenarios • Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads • Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions • Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes • Partner with manufacturing, quality, and external organizations to address CMC-related issues • Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers • Support planning and execution of Health Authority meetings, including mock sessions • Identify and implement process improvements to enhance regulatory efficiency and readiness • Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions • Ensure audit readiness and version control through meticulous documentation and system management