Position Title:  

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.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team.  The successful candidate 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 for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.

Responsibilities:

• 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

Experience and Skills:

• 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

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Position Summary:

The Senior Manager, Quality Assurance (QA), will report to the Director, QA Drug Substance and is primarily responsible for QA function for Cell Bank and Drug Substance (DS). The position is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Substances meet regulatory requirements and internal Vera standards.

Responsibilities:

• Support the oversight of the quality and compliance, primarily cell bank and biologics DS manufacturing.
• Support implementation of strategies and tactics to promote and maintain GxP compliance.
• Provide quality support on tech transfers.
• Liaise with CMO Quality partners to communicate QA policy and procedures.
• Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues.
• Responsible for material disposition of cell banks, commercial and clinical DS.
• Review executed batch records and associated documentation for material disposition.
• Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production.
• Provide quality support for validations including process validation, shipping validation, cleaning validation, etc.
• Provides support during both internal and regulatory agency audits as required.
• Perform Person-in-Plant duties, as required.
• Participate in Material Review Board as required.
• Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations.
• Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
• Participate in Quality Agreements negotiation with external partners.
• Support product lifecycle and continued process verification.
• Availability for 5-15% travel, both domestically and internationally.

Qualifications: 

• Bachelor’s degree with 10+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field or a Master’s degree with 7+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field.
• Minimum 6+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.
• Minimum 6+ years in a GMP QA role, and preferably direct work experience in either Manufacturing or QC, as well.
• Excellent written and verbal communication skills, including demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators.
• Innovative skills with problem solving and peer influence.
• In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements.
• Experience of working with external partners and biologics DS manufacturing.
• Experience working with Cell Bank is a plus.
• Experience with process validation is a plus.
• Strong attention to detail is a must.
• Excellent interpersonal, written and oral communication skills.
• Outstanding organizational skills.
• Ability to operate in a fast-paced, multi-disciplinary industrial environment.
• Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments.

Scientist I, In Vivo Pharmacology 

 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.

Nurix is seeking a motivated and detail‑oriented Scientist I/II to join our Preclinical Pharmacology group with a primary focus on in vivo pharmacology and pharmacokinetics (PKPD) and inflammatory and autoimmune diseases.

The position

We are seeking a highly skilled and motivated in vivo pharmacologist to lead efforts in inflammation. The ideal candidate will have expertise in small molecule PK/PD studies, inflammatory disease models, and immune cell profiling by flow cytometry. This hands‑on Scientist I/II role focuses on rodent models of inflammatory skin disease to characterize PK, PD, efficacy, and safety of therapeutic candidates. The candidate will establish new disease models in house. The scientist will design and execute skin inflammation studies, dose, collect and process blood, skin, and lymphoid tissues, and support ex vivo/in vitro immunology and molecular assays. The position is bench and vivarium based, requiring strong animal‑handling skills, experience with AD‑ and psoriasis‑like models, rigorous electronic documentation, and close collaboration with Discovery Research, DMPK, and other cross‑functional teams. At the Scientist II level, the individual will also be responsible for selected models or workflows, troubleshoot, implement technical improvements, and mentor junior staff.

This is an excellent opportunity for a hands‑on in vivo scientist who enjoys bench work and wants to contribute directly to the generation of high‑quality data that drive target validation, lead optimization, and clinical candidate selection.

Qualifications

Job level will be commensurate with experience.

• Ph.D. in pharmacology, cancer biology, immunology, or related field with relevant post-doctoral or industry experience; or B.S./M.S. in Pharmacology, Pharmaceutical Sciences, Biology, or related discipline
• Experience Sci I: typically ≥1 year (Ph.D.), ≥4 years (M.S.), or ≥8 years (B.S.)
• Experience Sci II: typically ≥4 year (Ph.D.), ≥8 years (M.S.), or ≥12 years (B.S.)
• Knowledge of PK/PD concepts and basic pharmacokinetic analysis
• Excellent hands-on skills, including IV, PO, intradermal, and topical dosing, and blood/tissue collection
• Experience with inflammation, immunology, or dermatology disease models (e.g., MC903/AD, imiquimod psoriasis, contact hypersensitivity, PCA, pruritus/itch, CIA, EAE) and associated clinical scoring.
• Experience with PD biomarker assessment (e.g., ELISA/multiplex cytokines, Western blot, flow cytometry, qPCR); multiparameter flow cytometry for immune cell phenotyping, ex vivo stimulation assays, cytokine release, or proliferation assays is preferred.
• Experience working with electronic lab notebooks and data analysis/graphing software (e.g., Excel, Prism, FlowJo or similar).
• Excellent communication and presentation skills, with strong interpersonal skills and the ability to work productively in a highly dynamic, cross-functional environment.

Fit with Nurix Culture and Values

• Strong team orientation; highly collaborative; solutions and results-oriented focus
• Strong scientific curiosity and initiative; hands-on and resourceful
• Self-driven and enthusiastic with the ability to thrive in a dynamic environment

Location: Brisbane, CA

Salary Range:

Scientist I:        $127,216.00 – $144,156.00

 Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix.  By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).