Positively contribute to the regulatory probability of success for clinical and commercial therapeutic programs. The Regulatory CMC Lead will oversee CMC Regulatory Affairs, working closely with subject matter experts and providing product strategy to commercial and clinical teams. Facilitate risk identification & mitigation strategies and oversee activities of junior regulatory personnel.

This position is responsible for providing Regulatory CMC strategies and leading the preparation of submissions and health authority interactions. Support development and execution of global Regulatory CMC strategies for Kyverna’s CAR T therapies, ensuring alignment with corporate objectives/timelines and regulatory compliance. Author and/or review high quality CMC sections for global regulatory submissions (IND/CTA, and BLA/MAA), applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines.

The Senior Regulatory Affairs Specialist, CMC is responsible for providing regulatory CMC support through the product life cycle, including regulatory strategies, submission timeline development, change control, and preparing submission documents. The role involves authoring and reviewing CMC regulatory documents, assessing CMC changes, and ensuring compliance with regulations.