New · posted Oct 15
Nurix Therapeutics · Biotechnology
Associate Director, Regulatory & Medical Writing
- Brisbane, CA
- On-site
- Full-time
- Director
Open until filled
The role
- Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as:
- Clinical study protocols and clinical protocol amendments
- Clinical study reports
- Investigator’s brochures and annual updates
- IND submissions and annual reports
- Lay-person summaries
- Integrated summary reports
- Clinical, nonclinical, and multidisciplinary information amendments
- NDA, BLA, MAA, and (e)CTD submissions
- Risk Management Plans
- Health authority responses
- Briefing documents, ODDs, BTDs/PRIME, FTD, and similar designations
- Review, edit, and QC documents developed by other authors or medical writers
- Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style
- Lead Regulatory & Medical Writing activities for assigned programs, including partnering with the Head of Regulatory & Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives
- Represent Regulatory & Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates
- Manage external Regulatory & Medical Writing resources for assigned programs/projects, as needed
Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients.
What you need
What You’ll Bring
- 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities
- Experience identifying and interpreting information/data for inclusion in documents such as clinical study protocols, Investigator’s Brochures, clinical study reports, Lay Summaries, and ICFs
- Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus
- Ability to work effectively and lead in cross-functional working groups
- Excellent communication skills, organizational skills, and attention to detail
- Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
- Knowledge of health authority requirements, ICH guidelines, and submission-ready standards relevant to document authoring, including eCTD and submission lifecycle management
- Proficiency in project planning tools such as MS Project or Smartsheet, collaborative authoring or document review tools, and Veeva RIM Suite
- Expertise in Microsoft Word (including use of customized toolbars/templates) and document management systems
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
$216,400 – $234,800 a year
Employer providedSalary Range: $216,400 - $234,800
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 4% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in California21 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $216,400 | — | $234,800 |
| California (middle half) | $223,000 | $244,000 | $282,500 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Nurix Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Nurix's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs15
- Regulatory submissions8
- Collaboration and leadership7
- Investigations and CAPA2
- Quality systems and risk2
- Lab testing and methods1
- Data and digital systems1
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.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
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%
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Associate Director, Regulatory & Medical Writing at Nurix
Open until filled. $216K–$235K a year, employer provided.