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Role Overview:
- Define and execute global regulatory strategy for autoimmune cell therapies.
- Serve as primary regulatory interface with FDA, EMA, and other authorities.
- Lead labeling strategy and negotiations to support commercial differentiation.
Responsibilities:
- Oversee preparation and submission of INDs, CTAs, BLAs/MAAs, and briefing packages.
- Provide regulatory input to program governance and portfolio decisions.
- Partner with Clinical, CMC, Commercial, and Legal teams.
Qualifications:
- Bachelor's degree required; advanced degree preferred.
- 15+ years of progressive regulatory experience with advanced therapies.
- Proven success in late-stage development and BLA/MAA submissions.
Compensation:
- National base salary range: $270K-$300K annually.
- Eligible for bonus, benefits, and stock plan participation.
Kyverna
Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.