Senior Regulatory Leader - Global Cell Therapy (Remote)

Kyverna Therapeutics; United States; On-site; USD 270,000 - 300,000; Full time

Benefits offered by this job

Bonus eligibility

Stock plan participation

Benefits package

Job summary

Kyverna Therapeutics is seeking an Executive Director, Regulatory Affairs to provide strategic and operational regulatory leadership across our cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.

The ideal candidate brings 15+ years in regulatory affairs, deep advanced therapy experience, and a proven ability to shape regulatory strategy from development through approval and launch, partnering with Clinical, CMC, Commercial, Market

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 15+ years in regulatory affairs within pharma/biotech, with advanced therapy exposure.
• Cell/gene therapy experience preferred; autoimmune focus advantageous.
• Proven success leading global regulatory strategies through late-stage development.
• Strong executive communication and cross-functional collaboration.

Responsibilities

• Lead global regulatory strategy across development, registration, and lifecycle management.
• Serve as senior interface with FDA, EMA, and other authorities.
• Drive labeling strategy from development through launch.
• Mentor and scale a high-performing regulatory team.
• Partner with Clinical, CMC, Commercial, Market Access and Legal.

Skills

Regulatory leadership

FDA interactions

Global regulatory strategy

Labeling strategy

Cross-functional leadership

Late-stage development

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Kyverna Therapeutics is seeking an Executive Director, Regulatory Affairs to provide strategic and operational regulatory leadership across our cell therapy portfolio, with a focus on commercial readiness, labeling strategy, and health authority engagement.

The ideal candidate brings 15+ years in regulatory affairs, deep advanced therapy experience, and a proven ability to shape regulatory strategy from development through approval and launch, partnering with Clinical, CMC, Commercial, Market