New · posted Oct 15
Nurix Therapeutics · Biotechnology
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)
- Brisbane, CA
- On-site
- Full-time
- Director
Open until filled
The role
- Report to the Senior Director, Regulatory Affairs CMC (Head of Regulatory CMC, Small Molecules) as a key member of the Regulatory Affairs team
- Develop, communicate, and execute global CMC regulatory strategies for assigned programs (drug substance and drug product) across the product lifecycle
- 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)
- Provide proactive CMC regulatory guidance and risk assessment to development, technical operations, and commercial teams
- 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
- 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
Shape the CMC regulatory path for Nurix's small molecule portfolio, from clinical development through marketed lifecycle. You'll combine hands-on authoring of Module 3 (Quality) content with real strategic influence as the CMC regulatory voice on cross-functional teams, with room at the Associate Director level to own strategy and mentor junior regulatory staff.
What you need
What You’ll Bring
- 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
- Minimum 6+ years in regulatory affairs with a substantial focus on CMC, and 10+ years of overall pharmaceutical/biotech industry experience
- Demonstrated experience authoring and/or compiling CMC (Module 3) content for regulatory submissions for small molecule products
- Working knowledge of ICH quality guidelines and of FDA and/or EMA CMC requirements; familiarity with other global regions is a plus
- Solid understanding of pharmaceutical development, manufacturing processes, and analytical methods for small molecules
- Strong written communication and scientific/technical writing skills
- Ability to manage multiple projects and competing timelines with attention to detail
- Effective cross-functional collaboration and stakeholder management
- Comfort operating with autonomy while escalating appropriately
The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.
Pay
$187,800 – $208,600 a year
Employer providedSalary Range: $187,800 - $208,600
Where you'll work
Brisbane, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Brisbane, CA
From the posting
About Nurix
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
About Nurix Therapeutics
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. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in California5 roles publishing pay
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $187,800 | — | $208,600 |
| California (middle half) | $204,500 | $241,000 | $248,000 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Nurix Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Nurix's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions5
- Lab testing and methods3
- Documentation and SOPs3
- GMP and compliance1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Nurix on Regulatory Jobs
- 11
- Open roles
- 11
- Distinct roles
- 1
- Locations
By discipline
- Quality6 55%
- Regulatory5 45%
By level
- Director7 64%
- Manager3 27%
- Senior & Principal1 9%
More roles at Nurix
- View role
Senior Scientist, Analytical Development and Quality Control - Early Phase
Brisbane, CASenior & PrincipalBiotechnology$162K–$186K
- View role
Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)
Brisbane, CADirectorBiotechnology$188K–$231K
- View role
Associate Director, Computer Systems Assurance (Quality)
Brisbane, CADirectorBiotechnologySalary not listed
- View role
Senior Manager, Analytical Development and Quality Control - Drug Product
Brisbane, CAManagerBiotechnology$161K–$186K
Similar Regulatory CMC roles elsewhere
- View role
Senior Director, Regulatory CMC
Marea TherapeuticsSouth San Francisco, CA · HybridDirectorBiotechnology$260K–$295K
- View role
Associate Director / Director, Regulatory Affairs - CMC
Iambic TherapeuticsSan Diego, CA · HybridDirectorBiotechnology$164K–$245K
- View role
Senior Director, Regulatory CMC
Summit TherapeuticsRemote, USDirectorBiotechnology$220K
- View role
Associate Director, Regulatory CMC
Praxis Precision MedicinesRemote, USDirectorBiotechnology$175K
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) at Nurix
Open until filled. $188K–$209K a year, employer provided.