Nurix Therapeutics

Nurix Therapeutics

Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)

Brisbane, California · Director

Sponsorship not specified$188k-$209kDetected 14 days ago
Product ManagementStakeholder ManagementSupply ChainPatient CareFDA RegulatoryCommunicationCollaborationMentoringWritingRegulatory Affairs

Stay score

odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level II · 2×
Level I$131,9551 entry
Level II$171,6422 entries
Level III$211,3283 entries
Level IV$251,0144 entries

Level III starts at $211,328 — $23,528 above the bottom of this range, and above its posted ceiling.

DOL prevailing wage, 2026-27 wage year · Managers, All Other (11-9199) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

2 transfer filings in the last year, covering 2 workers. Median labor-condition decision: 8 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

  • Author, review, and compile high-quality CMC (Module 3 / Quality) content for regulatory submissions, including IND/IMPD and equivalent global filings, amendments, annual reports, and responses to health authority questions
  • Assess the regulatory impact of manufacturing, analytical, formulation, and supply chain changes, and recommend filing strategies and categorization (e.g., substantial, non-substantial, annual reportable)

Responsibilities

  • Develop, communicate, and execute global CMC regulatory strategies for assigned programs (drug substance and drug product) across the product lifecycle
  • Partner with Technical Operations/Manufacturing, Analytical Development, Quality Control, Quality Assurance, Supply Chain, and CMOs/CDMOs (where applicable) to align technical activities with regulatory requirements
  • Represent CMC Regulatory on project and CMC sub-teams, and manage submission timelines and deliverables in coordination with regulatory operations and publishing
  • Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.

Nice to have

  • Report to the Senior Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecules) as a key member of the Regulatory Affairs team
  • Provide proactive CMC regulatory guidance and risk assessment to development, technical operations, and commercial teams
  • Ensure submission content is accurate, consistent, scientifically sound, and compliant with ICH guidelines and regional requirements (FDA, EMA, and other markets relevant to the portfolio)
  • Contribute to regulatory intelligence by monitoring evolving guidance and precedent and translating it into practical advice
  • Oversee quality assurance processes to ensure compliance with regulatory standards, and participate in cross-functional initiatives that improve regulatory submission processes and systems
  • At the Associate Director level, take greater strategic ownership and, where applicable, provide line management or mentoring of junior regulatory staff
  • Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or a related life sciences field is required
  • an advanced degree (M.S., Ph.D., or Pharm.D.) is preferred

Skills

  • Strong written communication and scientific/technical writing skills

Compensation

  • $187,800 - $208,600

This listing is sourced directly from Nurix Therapeutics's careers page and normalized into a canonical job model.