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:

As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.

Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities:

• Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecasting and maintaining budget for the regulatory writing team.
• Assess efficiencies, help identify areas of improvement and initiate improvement processes.
• Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
• Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summary
• Integrated summary reports
• Clinical, Nonclinical and Multidisciplinary Information Amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc
• Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications:

• Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

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 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:

ultradedicated – Your biggest challenges yield rare possibilities

The Senior Director, FP&A will be a key business partner to Ultragenyx’s Development organization, with primary responsibility for strengthening financial governance, budget transparency, and accrual rigor across development activities. The position supports the Chief Medical Officer and senior Development leadership by enabling a clear, consistent understanding of spend to date, remaining budget, and forward‑looking financial exposure across clinical and non‑clinical functions. The role combines hands‑on analytical execution with executive‑level financial storytelling to improve confidence, decision‑making, and stewardship across the development portfolio. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Establish and maintain strong working relationships with Development leadership and operational stakeholders, serving as a trusted finance partner embedded in clinical study governance, financial oversight, and execution forums.  
2. Provide hands‑on financial support to Program Teams and Development functions by reviewing invoices, tracking actual spend, and identifying total and remaining budget at the study, program, and functional levels.  
3. Lead clinical trial cost modeling, including scenario planning and sensitivity analyses, clearly explaining cost drivers related to study design, timelines, enrollment assumptions, and execution strategies.  
4. Perform regular budget‑to‑actual analyses across clinical and non‑clinical Development activities, synthesizing account‑level, vendor‑level, and study‑level variances into concise, decision‑oriented insights.  
5. Deliver clear, actionable financial updates on spend, forecast changes, risks, and opportunities to minimize surprises and strengthen confidence in Development financial outlooks.  
6. Partner with Accounting and operational teams to support Development accrual processes, ensuring assumptions are timely, well‑documented, and aligned with underlying operational activity.  
7. Lead financial communications related to clinical trials and broader Development spend, including inputs to executive‑level readouts, portfolio reviews, and CMO‑level presentations.  
8. Support annual planning and in‑year reforecasting cycles by reviewing business‑generated forecasts, assessing reasonableness, and providing Development‑wide financial context and challenge.  
9. Design, implement, and continuously improve financial tools, reporting, and processes that enhance budget visibility, accrual understanding, and financial fluency across Development teams.  
10. Balance near‑term execution and stewardship of existing processes with a longer‑term focus on strengthening governance frameworks, standardization, and transparency across Development financial management. 

Requirements:

1. Bachelor’s degree in finance, Accounting, Economics, or a related discipline; MBA, CPA, or advanced degree preferred.  
2. Minimum of 12 years of progressive experience in FP&A, finance, or financial management supporting R&D or development organizations within the biotechnology, pharmaceutical, or life sciences industry.  
3. Demonstrated experience partnering with Development teams, including Clinical Operations and non‑clinical functions such as Regulatory, Pharmacovigilance, Biostatistics, and Statistical Programming.  
4. Deep expertise in clinical trial financial modeling, including cost drivers, scenario planning, and sensitivity analysis, with the ability to translate operational assumptions into credible forecasts.  
5. Strong background in financial governance, including budget oversight, variance analysis, accrual support, and spend‑to‑date transparency.  
6. Proven ability to influence without formal authority and partner effectively with senior leaders, program teams, and functional stakeholders.  
7. Ability to operate seamlessly between strategic and detailed perspectives, including hands‑on engagement with invoices, actuals, and accrual drivers, as well as executive‑level synthesis.  
8. Demonstrated success leading process improvement initiatives that improve budget visibility, accrual rigor, and financial fluency within business teams.  
9. Strong communication skills, with the ability to deliver clear, concise summaries of variances, forecast changes, and drivers to audiences ranging from study teams to executives.  
10. Advanced proficiency in financial modeling, forecasting, and analytics tools (e.g., Excel, Adaptive Insights, and enterprise planning systems) 

#LI-CK1 #LI-Hybrid

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.

Position

The Senior Manager / Associate Director, Computer Systems Assurance (CSA) is an important technical and operational leader within the Nurix Quality Systems organization, responsible for owning and advancing Nurix's computer systems assurance program. As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix.

Reporting to the Vice President / Senior Director, Quality Systems, this individual will establish and maintain Nurix's risk-based CSA framework aligned with current regulatory expectations, including the FDA's 2022 guidance on computer software assurance, GAMP 5 (2nd edition), and applicable 21 CFR Part 11 and Annex 11 requirements. The role requires an individual who combines deep technical knowledge of GxP computerized systems with practical experience in SaaS and cloud-based platform qualification, and who can translate regulatory requirements into pragmatic, fit-for-purpose validation approaches that support a modern, agile biotech environment. This is a high-impact, program-ownership role requiring both strategic vision and hands-on execution. The successful candidate will work closely with Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors to ensure that all GxP-critical systems are appropriately assessed, validated, and maintained in a compliant state. The individual will champion a risk-based, science-driven approach to CSA across the organization.

Responsibilities

CSA Program Ownership and Strategy

• Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk-based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.
• Define and implement a fit-for-purpose, risk-tiered approach to system qualification for SaaS and cloud-hosted GxP applications, recognizing the vendor-managed nature of modern software platforms.
• Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope and rigor.
• Establish and maintain processes for vendor assessment, including review of vendor SOC 2 reports, quality agreements, and audit strategies appropriate for SaaS providers.
• Drive continuous improvement of the CSA program through benchmarking, regulatory intelligence, and adoption of industry best practices.

System Validation and Qualification Execution

• Lead and execute validation activities for GxP SaaS platforms including, but not limited to, eQMS (e.g., Veeva Vault), electronic document management, clinical data management, regulatory information management, and laboratory information systems.
• Author and review validation documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), Risk Assessments, Vendor Assessments, Validation Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Manage validation activities associated with system implementations, major configuration changes, upgrades, and periodic re-validation reviews, applying critical thinking to scope validation effort proportionate to system risk and change impact.
• Coordinate validation testing activities with cross-functional stakeholders; ensure test scripts are appropriately designed to demonstrate fitness for intended use.
• Review and approve validation deliverables prepared by internal teams, vendors, or external validation consultants.

21 CFR Part 11 and Data Integrity

• Serve as the internal subject matter expert for 21 CFR Part 11 and EU Annex 11 requirements; assess systems for compliance and provide guidance to cross-functional partners.
• Partner with IT and system owners to ensure electronic records and electronic signature controls are properly implemented and documented in all GxP systems.
• Support data integrity assessments and remediation initiatives; apply ALCOA+ principles to guide compliant system design and use.

Change Management and Periodic Review

• Manage the computerized systems change control process; evaluate proposed changes for validation impact and establish appropriate assessment, testing, and documentation requirements prior to implementation.
• Own and execute the periodic review program for validated GxP systems; assess continued fitness for intended use and compliance with current regulatory expectations.
• Maintain validation status documentation and ensure validation files are audit-ready at all times.

Inspection Readiness and Regulatory Support

• Support preparation for regulatory agency inspections; serve as the CSA subject matter expert during FDA, EMA, and other Health Authority inspections and ensure validation documentation is complete, current, and accessible.
• Contribute to relevant sections of regulatory submissions and respond to agency questions related to computerized systems and data integrity.
• Monitor evolving regulatory guidance and industry standards related to CSA, CSV, data integrity, and cloud-based systems; proactively adapt Nurix's program to reflect current expectations.

Cross-Functional Partnership and Training

• Serve as the primary point of contact and internal consultant for all GxP system owners across Quality, IT, Regulatory Affairs, CMC, and Clinical Operations.
• Develop and deliver CSA training for system owners, end users, and other stakeholders to build organizational capability and awareness.
• Partner with IT and vendor project teams to embed validation requirements early in system selection and implementation processes.

Required Qualifications

• Bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or a related field.
• 7–10+ years of progressive experience in computer systems validation and/or computer systems assurance in a GxP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
• Demonstrated expertise in current regulatory requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5 (2nd edition).
• Hands-on experience validating SaaS and cloud-hosted GxP platforms; understanding of vendor-managed environments and shared responsibility models.
• Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Strong working knowledge of data integrity principles (ALCOA+) and their application to electronic records management and GxP system design.
• Experience managing system change control and periodic review programs for validated GxP systems.
• Ability to operate as both program owner and individual contributor in a lean, virtual organizational model; comfortable managing validation activities without a large internal support team.
• Excellent written and verbal communication skills; able to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders.
• Strong organizational skills and attention to detail; demonstrated ability to manage multiple concurrent programs and priorities in a fast-paced environment.

Preferred Qualifications

• Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach and available supplier documentation.
• Familiarity with clinical development platforms such as electronic data capture (EDC), regulatory information management (RIM), or clinical trial management systems (CTMS) in a validated context.
• Experience supporting FDA, EMA, or equivalent Health Authority inspections as a CSA subject matter expert.
• Exposure to laboratory informatics systems (LIMS, ELN) and their GxP qualification requirements.
• Experience in a virtual or lean biotech environment managing validation activities through external vendors and consultants.
• Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance (e.g., NIST, SOC 2).
• Advanced degree in a relevant scientific, engineering, or regulatory discipline.

Fit with Nurix Culture and Values

• You know the regulations deeply and apply them with judgment, designing validation approaches that are rigorous where it matters and efficient everywhere else. You bring expertise with pragmatism —
• You are comfortable as the go-to expert, driving the CSA program forward proactively rather than waiting for direction, and you take accountability for outcomes. You own the program —
• You build trusted relationships across Quality, IT, and the business, and you understand that a well-designed, compliant systems environment is an enabler of Nurix's mission to develop important medicines for patients. You partner with purpose —

Location: Brisbane, CA - Onsite 

Salary Ranges: Senior Manager, CSA(Quality)      - $170,538 – $193,493                                  
                           Associate Director, CSA(Quality) - $190,269 – $216,360

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 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.

Position Summary:

The Manager, Accounting, will report to the Associate Director, Accounting and play a key role in supporting clinical and R&D accounting, as well as assisting with G&A accounting activities. This role will work closely with cross-functional teams throughout the company.

Responsibilities:

• Prepare and book journal entries for month-end close, including sub-ledger/ schedule to ledger reconciliations and analysis of reconciling items.
• Prepare R&D and contract manufacturing (CMC) accrual journal entries based on executed contracts and communications with department leads or vendors, maintaining related workbooks and roll-forwards.
• Prepare and manage clinical trial accruals for select CROs and vendors, maintaining accurate accounting workbooks and ensuring proper tracking of expenses.
• Track and maintain monthly accruals and prepaids for assigned vendors and accounts, collaborating with department leads to ensure accurate recording based on contracts and operational needs.
• Track and prepare open Purchase Order accruals based on contracts and services provided, working with PO owners to ensure timeline and accurate month-end accruals.
• Prepare prepaids amortization of assigned accounts and maintain accuracy of subledgers, ensuring that subledgers are maintained accurately and consistently.
• Continuously evaluate processes and recommend improvements to enhance efficiency and effectiveness.
• Maintain a thorough and current understanding of general ledger structure and ensure integrity and accuracy of financial data.
• Assist with SOX 404 efforts in documenting and performing the key controls in areas of responsibility.
• Supporting improvement of accounting policies and procedures to drive operational efficiency.
• Assist with annual audits and quarterly reviews, preparing audit schedules, and other audit requests.
• Provide support for special projects, initiatives, and ad-hoc analyses, as needed, or requested.

Qualifications:

• Bachelor’s degree in accounting, finance, or related field.
• 5+ years of relevant experience in biotech and/or pharmaceutical industry.
• Strong working knowledge of system processes, internal controls, GAAP and SOX regulations.
• Strong project management skills with the ability to anticipate events, prioritize assignments, deal with interruptions, and meet deadlines in a fast-paced and growth-oriented environment.
• Strong communication, project management, and organizational skills.
• Strong analytical skills and attention to detail.
• Ability to work independently as well as a collaborative team player.
• Self-starter, proactive, and willing to learn.
• Strong Excel skills
• Experience with inventory accounting in the pharmaceutical industry, a plus
• Experience with CRO/CMC accrual software, a plus.
• Certified Public Accountant (CPA), preferred.
• Experience with NetSuite, preferred.

Position Summary:

The Vice President, Regulatory Affairs will be responsible for the development and execution of the company’s Regulatory strategy and report into the Senior Vice President, Regulatory and Quality.  This critical hire will provide input, prioritize, implement, monitor, and communicate Vera’s Regulatory strategy and programs.  As part of the Quality and Regulatory leadership team, you will establish and translate Vera’s Regulatory strategy into operational policies, processes, procedures, and training to meet global regulatory, medical/health, and legislative standards.  This role requires experience, knowledge, and leadership credibility to be effective across Vera in multiple capacities, thereby ensuring compliance with Regulatory standards and corporate-wide commitment to Quality principles and Vera values.

Responsibilities:

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• In this highly visible role, the successful candidate will develop and lead integrated global regulatory strategies (US, EU, and key ex‑US markets) for all pipeline programs, aligning with overall corporate and clinical development goals.
• Serve as a primary regulatory strategist providing clear assessments of regulatory options, risks, and timelines to inform portfolio and investment decisions.
• Oversee planning, authoring, review, and submission of regulatory dossiers including pre‑IND/IMPD packages, INDs/CTAs, IBs, pediatric plans, orphan/expedited program requests, DSURs/PSURs, NDAs/BLAs/MAAs, and post‑approval supplements/variations.
• Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre-submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
• Partner closely with cross-functional teams to ensure clinical trial designs, endpoints, and statistical plans are aligned with regulatory expectations and support future registration.
• Oversee global CMC regulatory strategies, including module 3/quality sections, comparability plans, and lifecycle management; ensure alignment with GxP and ICH requirements.
• Ensure timely, accurate maintenance of all active INDs/CTAs and marketing authorizations, including safety reports, annual reports, labeling updates, and other commitments.
• Build, lead, and mentor a high‑performing regulatory team effectively leveraging external consultants, CROs, and vendors for eCTD publishing and ex‑US submissions.
• Establish and continuously improve phase‑appropriate regulatory processes, standards, and governance (e.g., submission planning, HA interaction tracking, labeling governance) suitable for a lean organization.
• Stay current on evolving global regulatory requirements, guidance, and precedent, and proactively incorporate learnings into program strategies and company policies.
• Support business development activities by contributing regulatory due diligence, risk/benefit assessments, and integration planning for potential partnerships, in‑licensing, and acquisitions.
• Represent Regulatory Affairs on cross‑functional governance bodies and, as needed, with partners, and external stakeholders.

Qualifications:

• Advanced degree in life sciences or related discipline (e.g., PhD, PharmD, MD, or MS); equivalent experience may be considered.
• 15+ years of increasing responsibility in biopharmaceutical regulatory affairs, including substantial experience in small or mid‑size biotech environments.
• Proven track record of leading major global submissions (IND/CTA and NDA/BLA/MAA or equivalent) through acceptance and, ideally, approval.
• Demonstrated experience interacting directly with FDA, EMA and other global health authorities, including leading meetings and negotiations on complex issues.
• Strong understanding of global regulatory frameworks (ICH, FDA, EMA and other regional requirements) across early development, registration, and post‑approval lifecycle management.
• Experience overseeing or partnering with CMC, regulatory operations/electronic submissions (eCTD), and safety/periodic reporting activities.
• Demonstrated ability to build, lead, and develop teams, and to work effectively as both a hands‑on individual contributor and strategic leader in a lean, fast‑paced biotech setting.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly to both technical and non‑technical audiences, including senior leadership and external partners.
• High degree of integrity, sound judgment, and a pragmatic, solutions‑oriented mindset with strong organizational and project management skills.

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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