Associate Director, Regulatory & Medical Writing

Regulatory Toolkit; California; On-site; USD 216,000 - 235,000; Full time

Job summary

Nurix Therapeutics is seeking an Associate Director of Regulatory & Medical Writing to independently lead authoring, review, and approval of key regulatory documents spanning clinical protocols to health authority submissions. You will ensure clarity, strategic messaging, and compliance with Nurix standards.

The role emphasizes cross-functional leadership, timely delivery, and strong documentation governance across multiple programs, including external resource management.

Qualifications

• 5+ years of Regulatory and/or Medical Writing experience in clinical development.
• Experience preparing documents for health authority submissions (eCTD, NDA/BLA/MAA).
• Ability to lead cross-functional workstreams and manage timelines.

Responsibilities

• Lead authoring, review, and approval of regulatory documents across the pipeline.
• QC documents and ensure content consistency and messaging.
• Manage authoring timelines and coordinate with external writers as needed.
• Represent Regulatory & Medical Writing on interdisciplinary teams and drive process improvements.
• Oversee external regulatory writing resources for assigned programs.

Skills

Regulatory writing

Medical writing

Cross-functional leadership

Communication skills

Organizational skills

Attention to detail

ICH guidelines

Submission lifecycle management

Tools

MS Project

Smartsheet

Veeva RIM Suite

Microsoft Word (advanced)

Job description

Associate Director, Regulatory & Medical Writing

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.

Position Description

The Opportunity

• 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

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

Salary Range:

$216,400 - $234,800

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.