California Designated Representative (Part-Time, Contract)

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Position Summary

Kyverna is looking for a California Designated Representative (DR) to serve as the representative of record with the California Board of Pharmacy (“CA BOP”).  This is a part-time, contract role requiring approximately 20–30 hours per week during active inspection periods, with a reduced commitment following inspections.

Time Commitment, Work Structure & Location

During inspection readiness and active inspections:

• ~20–30 hours per week
• Minimum 8 hours onsite per inspection period (or as required by regulators)

Post-inspection support:

• ~2 hours per week for up to 3 months
• Must be located within reasonable proximity to the facility to support onsite presence as needed, especially during inspections

Location:

• Emeryville, CA (ideally within 50 miles radius)

Hourly Range:

• $70-$90/hour

Regulatory Representation

• Serve as the Designated Representative of record with the CA BOP
• Attest to and sign regulatory documents, including forms, affidavits, and certifications
• Act as a point of contact for CA BOP regarding licensure, inspections, and compliance matters

Compliance Oversight (Virtual / Non-Handling Model)

• Be trained and maintain sufficient working knowledge of the company’s distribution model to accurately describe operations to CA BOP, including:
  • Use of contract manufacturers and packagers
  • Use of licensed third-party logistics providers (3PLs)
  • Product title transfer and distribution pathways

Inspections & Regulatory Inquiries

• Support CA BOP and third-party inspections in a representative capacity
• Respond to regulatory inquiries and clearly explain the company’s virtual operating model
• Be available onsite during inspections as required

Self-Assessments & Documentation

• Review and sign California-required self-assessment and self-inspection documentation
• Ensure documentation is complete, compliant, and available for regulatory review

• Active unrestricted California Pharmacist license in good standing
• Fulfill all CA BOP requirements for Designated Representatives
• Serve exclusively as the DR for only this licensed entity, in accordance with California law
• Prior experience serving as a Designated Representative or similar regulatory role preferred
• Strong understanding of California Board of Pharmacy regulations and pharmaceutical distribution models (including virtual/non-handling structures)
• Experience supporting regulatory inspections or audits
• Ability to interface effectively with regulators and cross-functional stakeholders
• While fully onsite presence is not required on a routine basis, availability for onsite inspections is mandatory
• Candidate should reside within a commutable distance to support regulatory expectations and inspection readiness

Salary : $70 - $90