New · posted Oct 15
Nurix Therapeutics · Biotechnology
Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)
- Brisbane, CA
- On-site
- Full-time
- Director
Open until filled
The role
In this role, you will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products.
Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)
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.
What you need
- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
- Must have minimum of 8 years in Regulatory affairs strategy
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory
- Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
- Ability to comply with changing regulatory
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Strong project management and critical thinking skills
- Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment
- Positive attitude, energetic and proactive
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others
What you'll do
- Provides regulatory strategic direction and support for assigned global development programs/development program activities
- Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
- Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
- Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
- Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
- Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
- Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
- Assist in the cataloging and maintenance of regulatory application submissions
- Conduct research and stay up-to-date on regulatory requirements and changes
- Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
- Monitor and assess regulatory risks and develop mitigation strategies
- Oversee quality assurance processes to ensure compliance with regulatory standards
- Review SOPs pertaining to Regulatory
- Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Participates in cross-functional process initiatives impacting regulatory submission processes and systems
- Manages consultants and contractors as needed
Pay
$187,800 – $231,200 a year
Employer providedSalary Range: SM $187,800 - $208,638 AD $199,500 - $231,200
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
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% 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 | $187,800 | — | $231,200 |
| 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 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions9
- Collaboration and leadership8
- Documentation and SOPs7
- GMP and compliance4
- Investigations and CAPA3
- 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.
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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Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) at Nurix
Open until filled. $188K–$231K a year, employer provided.