Remote Global Regulatory Strategy Director - Cell Therapies

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

Job summary

Kyverna Therapeutics seeks an Executive Director of Regulatory Affairs to lead global regulatory strategy for our autoimmune cell therapies from development through launch, shaping labeling and health authority engagement. You will partner with Clinical, CMC, Commercial, Market Access, and Legal to ensure submission readiness and lifecycle management, while building a high-performing regulatory team.

Remote role (West Coast hours preferred); reports to SVP, Chief Regulatory Officer; involves

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 15+ years of progressive regulatory affairs experience in pharma/biotech with cell therapy exposure.
• Cell/gene therapy experience and autoimmune disease exposure highly preferred.
• Proven track record leading global regulatory strategies through late-stage development and approvals.
• Experience with labeling strategy development and negotiation; understanding commercialization impact.
• Deep knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks.
• Strong executive communication and ability to influence senior leadership.

Responsibilities

• Lead global regulatory strategy for development programs from early development through post-approval.
• Act as primary interface with FDA, EMA, and other regulatory authorities.
• Oversee preparation and submission of INDs, BLAs/MAAs, CTAs, and other filings.
• Mentor and scale the regulatory team; establish policies and infrastructure.
• Ensure labeling strategy supports commercial objectives and lifecycle value.

Skills

Executive leadership

Global regulatory strategy

Regulatory affairs expertise

Stakeholder communication

Team leadership

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Kyverna Therapeutics seeks an Executive Director of Regulatory Affairs to lead global regulatory strategy for our autoimmune cell therapies from development through launch, shaping labeling and health authority engagement. You will partner with Clinical, CMC, Commercial, Market Access, and Legal to ensure submission readiness and lifecycle management, while building a high-performing regulatory team.

Remote role (West Coast hours preferred); reports to SVP, Chief Regulatory Officer; involves