Executive Director, Regulatory Affairs

Scorpion Therapeutics; United States; Remote; USD 300,000 - 600,000; Full time

Job summary

Kyverna Therapeutics is seeking a senior strategic leader to oversee global regulatory affairs for its cell therapy portfolio, guiding autoimmune programs from early development through commercialization. This executive role focuses on shaping regulatory strategy and leading cross-functional teams.

This executive will define regulatory strategy, lead FDA and global authority interactions, manage submissions (INDs, BLAs, MAAs), and mentor regulatory teams while collaborating with Clinical, CMC,

Qualifications

• 15+ years in pharma/biotech regulatory affairs with advanced therapies.
• Deep knowledge of global regulatory requirements and approvals (BLA/MAA).
• Proven track record leading late-stage development and regulatory success.

Responsibilities

• Define regulatory strategy and execution for global programs.
• Lead interactions with FDA and global authorities.
• Develop labeling and manage regulatory submissions (INDs, BLAs, MAAs).
• Oversee regulatory negotiations and policy establishment.
• Mentor regulatory teams and manage CRO/vendor activities.
• Collaborate cross-functionally with Clinical, CMC, Commercial, Market Access and Legal.

Skills

Regulatory strategy leadership

FDA/ICH/EMA knowledge

Executive leadership

Cross-functional collaboration

Education

Advanced degree

Job description

Senior strategic leader overseeing global regulatory affairs for Kyverna's cell therapy portfolio, focusing on autoimmune indications from early development through commercialization.

Responsibilities

• Define and execute regulatory strategies.
• Lead interactions with FDA and global authorities.
• Develop labeling.
• Manage submissions (INDs, BLAs, MAAs).
• Oversee regulatory negotiations.
• Collaborate cross-functionally with Clinical, CMC, Commercial, Market Access, and Legal teams.
• Lead and mentor regulatory teams.
• Establish policies.
• Manage CRO/vendor activities.

Requirements

• 15+ years in pharma/biotech regulatory affairs with significant experience in advanced therapies, ideally cell/gene therapy with autoimmune disease focus.
• Deep knowledge of FDA, ICH, EMA regulations; success in late-stage development and approvals (BLA/MAA).
• Strong leadership, strategic thinking, and executive communication skills.

Preferred

• Advanced degree.
• Autoimmune therapy experience.
• Global regulatory expertise.

Work setup

• Remote (West Coast hours preferred).
• Senior level with high-impact regulatory leadership.