Remote opportunity at
Kyverna TherapeuticsManager of Regulatory Affairs, Consultant
Kyverna Therapeutics seeks a Manager of Regulatory Affairs, Consultant to join its regulatory team on a remote basis, with a preference for West Coast hours. This…
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About This Role
Kyverna Therapeutics seeks a Manager of Regulatory Affairs, Consultant to join its regulatory team on a remote basis, with a preference for West Coast hours. This six-month contract position requires a 40-hour workweek. Kyverna Therapeutics is a clinical-stage biopharmaceutical organization dedicated to patient-centered care, developing advanced T cell engineering cell therapies to target and eliminate autoreactive immune cells driving autoimmune and inflammatory conditions. This role suits professionals with a background…
Job Description
Kyverna Therapeutics seeks a Manager of Regulatory Affairs, Consultant to join its regulatory team on a remote basis, with a preference for West Coast hours. This six-month contract position requires a 40-hour workweek. Kyverna Therapeutics is a clinical-stage biopharmaceutical organization dedicated to patient-centered care, developing advanced T cell engineering cell therapies to target and eliminate autoreactive immune cells driving autoimmune and inflammatory conditions. This role suits professionals with a background in biotechnology or pharmaceutical regulatory affairs who want to help shape regulatory strategies and interact with health authorities for innovative treatments.
Responsibilities
- Contribute to regulatory strategy development and execution aligned with company goals
- Plan and coordinate regulatory submissions and health authority interactions
- Prepare, review, and manage INDs, CTAs, amendments, BLAs, annual reports, and safety reports
- Coordinate company responses to regulatory agency queries
- Ensure documentation complies with global regulatory standards
- Partner with Quality Assurance and other departments to maintain GXP compliance
- Participate in regulatory audits and inspections
- Act as the regulatory lead for study-level management teams
- Monitor regulatory environment shifts and evaluate their effects on development plans
Requirements
- 2 to 5+ years of industry experience in Regulatory Affairs within pharma or biotech
- Familiarity with ICH guidelines, regional regulations, and global trends
- Background working with cell or gene therapy regulatory affairs
- Experience handling CTD, eCTD, and life cycle management
- Project management capabilities with strong organizational skills and attention to detail
- Interpersonal abilities suited for cross-functional collaboration
Qualifications
- Bachelor’s degree or advanced degree in a relevant scientific discipline
Core Skills
Benefits
- Hourly rate between $75 and $85 per hour
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the role is remote, though West Coast hours are preferred.
What is the compensation for this role?
The hourly rate ranges from $75 to $85 per hour.
What is the expected duration and time commitment?
This is a six-month contract position requiring 40 hours per week.
What experience is required to apply?
Applicants need two to five-plus years of biotechnology or pharmaceutical industry experience in Regulatory Affairs, including background in cell or gene therapy regulatory affairs.
Sample Interview Questions
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