Remote Regulatory Affairs Consultant, Cell Therapy

Kyverna Therapeutics; Oregon; Hybrid; USD 103,000 - 117,000; Full time

Job summary

Kyverna Therapeutics is seeking an experienced Regulatory Affairs Consultant to join our regulatory team in a contract position. This remote role contributes to regulatory strategy for innovative cell therapies and interfaces with health authorities to drive submissions.

Responsibilities include planning and coordinating regulatory submissions (INDs/CTAs and amendments), leading interactions with CROs, ensuring CTD/eCTD readiness, and maintaining compliance with global guidelines.

Qualifications

• Minimum 2–5+ years in Regulatory Affairs within biotech/pharma.
• Experience with regulatory requirements (ICH, regional) and lifecycles.
• Experience with cell or gene therapy regulatory affairs preferred.
• EU CT A / CTIS experience is a plus.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Contribute to development and execution of regulatory strategies aligned with timelines.
• Coordinate regulatory submissions and interactions with health authorities.
• Lead preparation and review of INDs/CTAs and amendments, etc.
• Ensure regulatory documents comply with global requirements and guidelines.
• Collaborate with QA and other teams to maintain GXP compliance.

Skills

Regulatory strategy

Global submission planning

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor's or advanced degree in a relevant scientific field

Tools

CTD/eCTD

Job description

Kyverna Therapeutics is seeking an experienced Regulatory Affairs Consultant to join our regulatory team in a contract position. This remote role contributes to regulatory strategy for innovative cell therapies and interfaces with health authorities to drive submissions.

Responsibilities include planning and coordinating regulatory submissions (INDs/CTAs and amendments), leading interactions with CROs, ensuring CTD/eCTD readiness, and maintaining compliance with global guidelines.