University of California , San Francisco

Product Compliance Specialist

US

Sponsorship not specifiedDetected 92 days ago
Project ManagementForecastingSupply ChainGMPFDA RegulatoryResearchLeadershipCommunicationProblem SolvingPublic SpeakingRegulatory Affairs

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odds of building a lasting career here

88Lottery-free
Cap-exempt (no lottery)100
Sponsors year-round90
Entry-level history60
PERM / green-card track50
Fits your clock70

Files H-1B any time — no cap, no lottery. The 2026 weighted-selection rule doesn't touch it, which makes this the strongest structural path for entry-level talent. Pay is often lower, but your odds of staying are dramatically higher.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

States it is exempt from the H-1B cap

In 2 Department of Labor filings, this employer states it is an institution of higher education — one of the statutory grounds for exemption from the H-1B cap. Cap-exempt employers can file year-round without entering the lottery.Employer's own attestation on a Department of Labor wage determination, not a USCIS determination — exemption is decided per petition.

Files H-1B transfers

22 transfer filings in the last year, covering 22 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and compliance with federal, state, and University mandated laws, regulations and policies.
  • The role requires ongoing cross-functional engagement with CMO manufacturing and IRT teams, the Regulatory Sponsor, and federal stakeholders to ensure alignment, quality, and timely execution.

Responsibilities

  • Serve as the primary CMC lead interfacing with the CMO's internal functional groups (Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, Analytical Development, Validation) and external partners/sponsors.
  • Drive alignment across technical teams to ensure process development, scale-up, validation, and commercial readiness milestones are met.
  • Identify cross-functional risks and proactively implement mitigation strategies.
  • 25% Yes Manage the CMO's project timelines and budgets related to CMC activities.
  • Develop and maintain detailed CMC project timelines spanning development, validation, regulatory submission, and lifecycle management phases.
  • Stability program design and monitoring

Requirements

  • Bachelor's degree in related areas
  • 5 years of related experience
  • Proficiency in communicating complex scientific data to technical and non-technical audiences
  • Strong proficiency in public speaking, and writing
  • Technical leader with a high degree of knowledge in the overall field and recognized expertise in specific areas
  • functions with a high degree of autonomy.

Nice to have

  • Master's degree or PhD in related area and / or equivalent experience and training.
  • Relevant compliance certification (if applicable) preferred.

Visa & Work Authorization

  • The role requires ongoing cross-functional engagement with CMO manufacturing and IRT teams, the Regulatory Sponsor, and federal stakeholders to ensure alignment, quality, and timely execution.
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This listing is sourced directly from University of California , San Francisco's careers page and normalized into a canonical job model.