Hybrid California Designated Representative – Part-Time, Contract

Posted 18 hours ago

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About the role

  • California Designated Representative ensuring regulatory compliance with the CA Board of Pharmacy for biopharmaceutical company. Part-time, contract role requiring onsite presence during inspections in Emeryville.

Responsibilities

  • 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

Job title

California Designated Representative – Part-Time, Contract

Job type

Experience level

Mid levelSenior

Salary

$75 - $90 per hour

Degree requirement

No Education Requirement

Location requirements

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