Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) Employer Nurix Therapeutics Location Brisbane, California, United States Start date May 8, 2026 View more categories View less categories Discipline Marketing , Regulatory , Science/R D , Oncology Required Education Bachelors Degree Position Type Full time Hotbed Biotech Bay Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job

Job Details Company Job Details 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/ ). Company Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.

Company info Website https:

//www.nurixtx.com/ Phone 415-660-5320 Location 1700 Owens Street Suite 205 San Francisco California 94158 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert