---
title: 'Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) at Nurix'
canonical: 'https://feeny.ai/job/senior-manager-associate-director-regulatory-affairs-cmc-small-molecules-nurix-pp3fh8jc68k1'
type: 'job'
last_seen: '2026-10-15'
---

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

- **Company:** Nurix
- **Location:** Brisbane, CA
- **Posted:** 2026-10-08
- **Last confirmed live:** 2026-10-15
- **Apply:** https://job-boards.greenhouse.io/nurix/jobs/8879732002

## Job description

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

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.

Position Description

The Opportunity

- 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

## 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

Salary Range:  $187,800 - $208,600

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.

Location:          Onsite – Brisbane, CA

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.

## About Nurix

## Company Overview
- **One-liner**: Nurix Therapeutics is a clinical-stage biopharmaceutical company pioneering targeted protein degradation medicines to outmatch disease by harnessing the cell’s natural protein disposal system.
- **Entity Type**: Public (NASDAQ: NRIX)
- **Headquarters**: San Francisco, California, USA
- **Founded**: 2009
- **Founders**: Not publicly listed as individual founders; the company was spun out from research at UC Berkeley and UC San Francisco.

## Core Business
- **Primary industry**: Biopharmaceuticals / Targeted Protein Degradation
- **Target customers**: B2B (pharma partners) and B2C (patients via clinical trials and eventual commercial therapies); enterprise-level partnerships with major pharma.
- **Mission or purpose statement**: "Writing medicine’s next chapter using targeted protein degradation as a new script to outmatch disease." [nurixtx.com](https://www.nurixtx.com/)

## Products & Services
- **Bexobrutideg (NX-5948)**: A potential best-in-class BTK degrader in Phase 1b/2 clinical trials for relapsed/refractory CLL/SLL and chronic spontaneous urticaria. Co-developed and co-commercialized with Roche under a global collaboration announced June 2026. [nurixtx.com](https://www.nurixtx.com/)
- **NX-2127**: A BTK degrader in clinical development for B-cell malignancies.
- **CBL-B Inhibitor (NX-1607)**: An E3 ligase inhibitor designed to activate T cells for immuno-oncology, in Phase 1 clinical trials.
- **IRAK4 Degrader**: A partnered program with Gilead in Phase 1 for inflammatory diseases.
- **STAT6 Degrader**: A partnered program with Sanofi in IND-enabling studies.
- **DEL-AI Discovery Engine**: A proprietary, fully AI-integrated platform combining DNA-encoded libraries (DEL), automated chemistry, and machine learning to design and optimize targeted protein degraders and degrader-antibody conjugates (DACs).

## Market Standing
- **Valuation/Market Cap**: Not publicly available in the provided search results; as a public company (NRIX), market cap fluctuates daily. Check financial platforms for the latest figure.
- **Key Metric**: Annual Revenue (public) — Not publicly available in the provided search results; as a clinical-stage biotech, revenue is typically minimal or pre-revenue. Total funding raised prior to IPO is not detailed in the provided results.
- **Notable Investors/Partners**: Roche (global co-development and co-commercialization collaboration for bexobrutideg, announced June 2026), Gilead (partnered IRAK4 degrader program), Sanofi (partnered STAT6 degrader program).
- **Growth Signals**: Announced a landmark global collaboration with Roche in June 2026 to co-develop and co-commercialize bexobrutideg across malignant hematology, immunology, and neurology. Presented positive Phase 1a/b data for bexobrutideg in CLL/SLL and chronic spontaneous urticaria in 2026. Multiple partnered and wholly owned pipeline programs advancing through clinical and preclinical stages.

## Competitive Advantages
- **Proprietary DEL-AI Discovery Engine**: A fully AI-integrated platform combining DNA-encoded libraries, automated chemistry, and machine learning to design degraders against any protein class, providing a significant speed and innovation advantage. [nurixtx.com](https://www.nurixtx.com/)
- **Unparalleled Ligase Expertise**: Deep understanding of E3 ligase biochemistry and biology, a critical and complex component of the protein degradation mechanism, giving them a unique moat.
- **Multi-Modal Pipeline**: Developing both small molecule degraders and Degrader-Antibody Conjugates (DACs), expanding the therapeutic reach and creating multiple shots on goal.
- **Strong Partnership Network**: Collaborations with top-tier pharma (Roche, Gilead, Sanofi) validate their platform and provide non-dilutive funding and shared risk.

## Strategic Focus
- **Clinical Advancement**: Driving lead asset bexobrutideg through pivotal trials in CLL/SLL and expanding into immunology (chronic spontaneous urticaria) and neurology.
- **Platform Expansion**: Leveraging the DEL-AI engine to develop Degrader-Antibody Conjugates (DACs) for enhanced cell specificity and safety.
- **Pipeline Breadth**: Advancing a multi-modal pipeline across oncology, immunology, and neurology, both wholly owned and through strategic partnerships.
- **Partnership Leverage**: Deepening collaborations with Roche, Gilead, and Sanofi to co-develop and co-commercialize programs, reducing risk and accelerating timelines.

## Why Work Here
- **Culture**: Mission-focused, values-based, and spirited culture emphasizing "breakthrough innovation," "leadership," "accountability," and "zealousness." Employees are encouraged to "think big and act bold." [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
- **Work with Industry Leaders**: The team includes scientific innovators who built the protein degradation field, seasoned executives with biotech scaling expertise, and leading clinicians. [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
- **Growth & Impact**: Employees can "wear many hats" and gain broad exposure in a lean, virtual drug developer environment. The company emphasizes career growth and opportunity-rich experiences.
- **Work Policy**: Onsite in Brisbane, CA (San Francisco Bay Area) for most roles, as indicated by job postings. [nurixtx.com](https://www.nurixtx.com/explore-jobs/)
- **Benefits**: Comprehensive health and welfare plans, enhanced parental leave, wellness reimbursement, 401(k) employer match, and a highly collaborative culture. [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
- **Engineering/Science Culture**: Described as "mission-focused, values-based, and spirited," with a focus on "intellectual and technical ingenuity" and "intelligent risk-taking." The company is a "virtual drug developer" with a lean internal infrastructure, relying on SaaS and cloud platforms. [nurixtx.com](https://www.nurixtx.com/explore-jobs/)

## Sources
1. [nurixtx.com](https://www.nurixtx.com/)
2. [nurixtx.com](https://www.nurixtx.com/work-at-nurix/)
3. [nurixtx.com](https://www.nurixtx.com/explore-jobs/)
4. [nurixtx.com](https://www.nurixtx.com/our-story/)

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