California Designated Representative – Part-Time, Contract
Kyverna Therapeutics
contract
Posted on:
Location Type: Hybrid
Location: Emeryville • California • United States
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Salary
💰 $75 - $90 per hour
About the role
- 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
- 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
- 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
- Review and sign California-required self-assessment and self-inspection documentation
- Ensure documentation is complete, compliant, and available for regulatory review
Requirements
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
California Pharmacist licenseregulatory document signingself-assessment documentationself-inspection documentationcompliance reviewregulatory inquiry responsepharmaceutical distribution modelscontract manufacturingthird-party logisticsproduct title transfer
Soft Skills
interpersonal communicationstakeholder engagementregulatory interfaceproblem-solvingattention to detailorganizational skillsadaptabilityteam collaborationtime managementavailability for inspections
Certifications
active unrestricted California Pharmacist license