Position Title:   Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

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 Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will serve as the global regulatory lead (GRL) for the immunology and inflation therapeutic area. This role will be responsible for developing 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 early development, 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. This position is on site in the Brisbane, CA office.

Responsibilities:

• Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
• Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
• 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
• Lead 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
• Manages consultants and contractors as needed

Requirements

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation 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., 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

Salary Range:  220K – 254K plus bonus and equity.

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 (BTK), a B-cell signaling protein, and an inhibitor of Casitas B-lineage lymphoma proto-oncogene-B (CBL-B), an E3 ligase that regulates T cell activation.  Nurix is also progressing multiple programs through partnership, including an IRAK4 degrader in Phase 1 in partnership with Gilead and a STAT6 degrader in IND enabling studies with Sanofi.  Multiple additional wholly owned and partnered programs are at various stages of preclinical development.

Position:

Reporting to the Director, Regulatory Affairs Project Management and Operations, the Senior Associate, Regulatory Operations provides key support to the Nurix Regulatory Affairs department. This position has responsibility for entry-level coordination, review, assembly and archival of regulatory submissions in Veeva RIMS and documents for health authorities (US FDA and global equivalents).  The Senior Associate, Regulatory Operations will provide support for multiple regulatory activities, studies, and programs. The individual will have responsibility to understand and implement regulatory guidance and help ensure regulatory compliance for assigned projects.  The Senior Associate should have 2–3 years’ experience in Regulatory Affairs or Regulatory Operations. Working knowledge of at least one functional discipline (e.g. Regulatory, Clinical, Nonclinical, Clinical Pharmacology or Chemistry Manufacturing and Controls) and a general knowledge of clinical development preferred.  The candidate should have a can-do attitude and experience working in Veeva RIMS. Also, the candidate should be eager to learn regulatory and clinical trial requirements, best practices, and provide support for Regulatory programs and leadership. 

Responsibilities:

• Under the strategic direction of the SVP of Regulatory Affairs and the Director of Regulatory Affairs PM and Operations, the candidate will support the planning, coordination, tracking and execution of submissions and responses to global regulatory authorities
• Assist Regulatory team, project teams and Clinical Research Organization (CRO) counterparts in the implementation of regulatory plans, timely delivery, and submission of regulatory documentation
• Preparation of Regulatory submission documentation (e.g Forms, Cover Letter) as requested
• Support team with formatting, QC and publishing of submission documents and packages
• Manage and support Veeva RIMS processes such as HAI, SCP and Archiving
• Manage authoring and review workflow in Veeva RIMS according to defined timelines
• Coordinate with regulatory colleagues and cross-functional departments to prepare, compile, review, and submit documents or information necessary to health authorities in accordance with regulations, guidelines or queries IN Veeva RIMS using SCP
• Maintain archival copies of health authority submissions (e.g., IND, CTA, NDA, and MAA), correspondence and a record of health authority obligations, and commitments
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration. Participate in Regulatory Intelligence activities to help inform team members of new applicable guidelines and conduct training sessions on new guidelines/regulations if necessary
• Participate in kick-off and project-based meetings related to regulatory submissions, strategy, and comment resolution. Be a reliable resource for information following such meetings
• Follow general instructions from Regulatory management or company leadership for assigned projects while independently planning daily work tasks to complete projects on time. Seek guidance on project/task priorities as needed
• Communicate important project decisions or challenges to Regulatory leadership
• Create or contribute to Standard Operating Procedures (SOP), checklists and training Materials for Regulatory department activities
• Support contracts and Purchase order for the Regulatory Affairs department

Requirements:

• Bachelor's Degree in Life Sciences or relevant field
• Minimum of 4-5 years’ experience working in Regulatory Affairs or Regulatory Operations Additional experience in the biotechnology or pharmaceutical industry preferred
• Understanding of the drug development process
• Proficient knowledge of Veeva RIMS SCP, workflows, archival, reporting…
• Experienced publisher (DocuBridge, GlobalSubmit, VeevaVault Submission…)
• Experience successfully supporting critical deliverables while maintaining agreed timelines
• Demonstrated ability to work effectively with cross-functional teams or collaborative environments.
• Basic knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
• Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus.
• Previous experience with maintaining in-house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (e.g., Veeva) is a plus.
• Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
• Superior communication skills: oral, written, with proven negotiation skills, and strong time-management.
• Excellent Computer Skills MS Word, Excel, Power Point, Smartsheet and document management software/system, templates.
• Ability to work on multiple tasks and prioritize tasks to meet company objectives. Strong attention to detail and time management skills are essential.

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.

Salary Range:   140K - 160K  plus bonus & equity.

Location:  Brisbane, CA (Onsite role)

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