New · posted Oct 15
Nurix Therapeutics · Biotechnology
Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)
- Brisbane, CA
- On-site
- Full-time
- Director
Open until filled
The role
Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology – Solid Tumors) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the SVP, Head of Regulatory Affairs and other cross-functional colleagues. This role will be responsible for developing and executing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities. This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.
What you need
- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
- Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the oncology (solid tumors) therapeutic area
- 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
- 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., Veeva RIM, Smartsheet, Excel trackers, etc) 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
- Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
- Identify potential risks and mitigation strategies associated with proposed strategies
- Represent Regulatory Affairs on assigned cross-functional development teams.
- Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
- Support communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
- Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
- Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
- Ensure adherence to current regulations associated with regulatory activities
- 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
- Manage consultants and contractors as needed
Pay
$232,000 – $274,000 a year
Employer providedSalary Range: Director: $232K - $274K
Where you'll work
Brisbane, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Brisbane, CA
From the posting
About Nurix
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
Senior Director: $279K - $331K
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% above 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 | $232,000 | — | $274,000 |
| 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 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions12
- Collaboration and leadership9
- Documentation and SOPs5
- GMP and compliance3
- Investigations and CAPA1
- 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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Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors) at Nurix
Open until filled. $232K–$274K a year, employer provided.