Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Position Summary
The Senior Manager, Regulatory Operations will be responsible for the end-to-end execution and oversight of regulatory submissions across the company’s cell therapy portfolio. This role is critical to ensuring high-quality, compliant, and timely regulatory submissions to global health authorities, including FDA, EMA, and other international agencies.
The ideal candidate brings deep hands-on regulatory operations expertise in an IND-stage or BLA-preparing environment, thrives in fast-paced biotech settings, and partners closely with Regulatory Affairs, CMC, Clinical, and Quality teams.
Title: Sr. Manager, Regulatory Operations
Location: Remote with west coast hours
Reports to: Executive Director, Regulatory Operations