Regulatory Affairs, Consultant
Kyverna Therapeutics
- Pay
- $75 to $85
- an hour
- Location
- United States
- Work style
- Remote only
- Job type
- Full time
- Posted
- Oct 20
- 4 days ago
Career path
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About the company
Kyverna Therapeutics
Biotechnology · 51 to 200 employees
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases.
What you'll do
- Shape and execute regulatory strategies for innovative therapies
What you need
- Bachelor's or advanced degree in a relevant scientific field. Minimum of 2-5+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. Experience with cell or gene therapy Regulatory Affairs preferred. EU C TA / CTIS experienced Experience with CTD/eCTD and life cycle management. High attention to detail, strong organizational skills, and project management capabilities. Effective communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams. Ability to adapt to a dynamic regulatory environment.
Key skills
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