• Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions, including INDs, CTAs, and amendments. • Assist with compiling technical data from Manufacturing, QA, and QC teams to support submissions. • Maintain and track regulatory submission timelines and deliverables. • Support responses to health authority information requests related to CMC topics. • Review and assess change controls to determine potential regulatory impact and filing requirements. • Maintain awareness of relevant regulatory guidance, ICH guidelines, and agency expectations for cell/gene therapies. • Help ensure documentation and submissions meet current regulatory standards and internal quality requirements. • Collaborate effectively with cross-functional partners in Process Development, Manufacturing, QA, QC, and Regulatory Affairs. • Participate in project team meetings and provide CMC regulatory support under the guidance of senior regulatory staff. • Assist with developing or revising SOPs, working instructions, and templates used in Regulatory CMC activities. • Participate in the organization of regulatory archives and tracking systems for submission history and regulatory documentation.