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.

In this role, you will manage all aspects related to Regulatory Affairs and Pharmacovigilance in connection with Expanded Access Programs (EAPs). This includes developing regulatory strategies, consulting clients, and managing complex projects to ensure EAPs are executed according to plan and in compliance with regulatory requirements and client expectations. Be a leader in a growing company.