Job description
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. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.
Kyverna is seeking an experienced and driven Associate Director of Regulatory Affairs to join our regulatory team. We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.
Job Title: Associate Director of Regulatory Affairs
Location: Emeryville, CA – Hybrid OR Remote
Reports To: SVP, Chief Regulatory Officer
Responsibilities
Regulatory Strategy
Contribute to the development and implementation of regulatory strategies aligned with corporate goals and timelines.
Assist in planning and coordinating regulatory submissions and interactions with health authorities.
Assist in preparation for FDA Advisory Committee meeting
Regulatory Submissions
Prepare, review, compile, and archive regulatory documents, including but not limited to Investigational New Drug (IND) applications, Biologics License Applications (BLA), Regenerative Medicine Advanced Therapy (RMAT) designations, Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), Orphan Drug Designations (ODDs), Pediatric Investigational Plans (PIPs), SUSAR reports, and Development Safety Update Reports (DSURs).
Regulatory Lead in preparation of labeling and USPI
Ensure all submissions meet global regulatory requirements and are in full compliance with applicable guidelines.
Regulatory Expertise
Apply regulatory knowledge to provide strategic guidance and support cross-functional regulatory planning.
Monitor regulatory trends, evolving requirements, and industry best practices to inform internal processes.
Quality and Compliance
Partner with Quality Assurance and Regulatory Affairs to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.
Support preparation for and participation in regulatory inspections and audits.
Cross-Functional Collaboration
Work closely with teams across Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other functions to ensure regulatory alignment with overall development objectives.
Regulatory Intelligence
Maintain awareness of changes in the global regulatory landscape affecting company products.
Evaluate the potential impact of new or revised regulations and communicate implications for development strategies and timelines.
Requirements
- Bachelor’s or advanced degree in a relevant scientific field.
- 9+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.
- Highly experienced in EU clinical trial applications
- Proficiency in global regulatory requirements and guidelines.
- Experience in preparing regulatory submissions, including INDs, and MAAs.
- High attention to detail, very 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.
The salary range for this position based in No. Cal. is from $180,000 - $205,000 annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
