Nurix Therapeutics

Nurix Therapeutics

Senior Manager, Regulatory Operations

Brisbane, CA · Senior

Sponsorship not specified$140k-$162kDetected 3 days ago
GCPComplianceProject ManagementNegotiationExcelClinical TrialsClinical ResearchPharmacologyGMPFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationTime ManagementRegulatory Affairs

About the role

  • 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 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.

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
  • 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
  • Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration.
  • 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
  • Reporting to the Director, Regulatory Affairs Project Management and Operations, the Senior Manager, Regulatory Operations provides key support to the Nurix Regulatory Affairs department.
  • The Senior Manager, 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.

Requirements

  • Bachelor's Degree in Life Sciences or relevant field
  • Proficient knowledge of Veeva RIMS SCP, workflows, archival, reporting…
  • 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.
  • Superior communication skills: oral, written, with proven negotiation skills, and strong time-management.
  • Ability to work on multiple tasks and prioritize tasks to meet company objectives.
  • The candidate should have a can-do attitude and experience working in Veeva RIMS.

Nice to have

  • Minimum of 5 years' experience working in Regulatory Affairs or Regulatory Operations.
  • Additional experience in the biotechnology or pharmaceutical industry preferred

Skills

  • Nurix is located in Brisbane, CA - this is an onsite position.
  • Strong team orientation; highly collaborative
  • Solutions and results-oriented focus
  • Hands-on approach; resourceful and open to diverse points of view.
  • oral, written, with proven negotiation skills, and strong time-management.
  • Fit with Nurix Culture and Values

Compensation

  • Salary Range: 140K - 162K plus bonus & equity.

Benefits

  • 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).
  • Maintain archival copies of health authority submissions (e.g., IND, CTA, NDA, and MAA), correspondence and a record of health authority obligations, and commitments
  • 140K - 162K plus bonus & equity.

Company info

  • 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.
  • 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.
  • 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.
  • The Senior Manager should have 5 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.
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