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
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