Executive Director Regulatory Affairs

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.

Title: Executive Director, Regulatory Affairs

Location: Remote (West Coast hours preferred)

Reports to: SVP, Chief Regulatory Officer

Position Overview

The Executive Director, Regulatory Affairs will provide strategic and operational regulatory leadership across Kyverna's cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.

The ideal candidate is a seasoned regulatory leader with deep experience in advanced therapies who can shape regulatory strategy from early development through approval and launch, while partnering closely with Clinical, CMC, Commercial, Market Access, and Legal teams.

The Executive Director will define and execute global regulatory strategy to support clinical development, registration, and commercialization of Kyverna's autoimmune cell therapies. The role requires the ability to translate scientific and clinical data into approvable, commercially viable labeling and to lead interactions with regulatory authorities, including FDA and global counterparts.

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Responsibilities
Regulatory Strategy & Leadership

Lead global regulatory strategy for Kyverna's development programs, aligning clinical, CMC, and commercial objectives from early development through post-approval lifecycle management.

Provide regulatory input to program governance, asset prioritization, and portfolio decisions, including scenario planning and risk mitigation.

Anticipate and address regulatory challenges related to cell therapy development, manufacturing, comparability, and long-term follow-up.

Health Authority Engagement & Negotiations

Serve as the primary senior regulatory interface with FDA, EMA, and other global health authorities.

Lead and/or support key regulatory meetings, including INTERACT, pre-IND, End-of-Phase, pre-BLA/MAA, Advisory Committees, and post-marketing commitments.

Drive regulatory negotiation strategy, including benefit-risk, endpoints, comparability, and post-approval requirements.

Labeling Strategy & Commercial Readiness

Own and drive labeling strategy from early development through approval, ensuring labels support commercial differentiation, patient access, and lifecycle value.

Lead development of Target Product Profiles (TPPs) and ensure alignment across Clinical, Regulatory, Commercial, and Market Access.