Regulatory Affairs – CMC Specialist, Cell Therapy Products

Regulatory Affairs – CMC Specialist, Cell Therapy Products

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.


We are seeking to hire an experienced CMC regulatory specialist/manager to support the preparation and maintenance of CMC regulatory submissions to FDA and other Regulatory Agencies for Adoptive T Cell therapy products.

Key responsibilities:

  • Closely collaborate with the T-Cell process development and manufacturing teams to develop regulatory CMC documentation for IND submissions and /or submission to ex-US Regulatory Agencies
  • Maintain ongoing knowledge of FDA and international regulations and guidelines, as well as current practice for CMC submissions including those specific to Adoptive T-cell production, and advise manufacturing and QC teams accordingly
  • Review and compile regulatory CMC documentation for IND submissions within corporate timelines
  • Authoring CMC documentation/summaries from manufacturing, testing, and stability reports.
  • Coordinate eCTD building with publishing CRO
  • Contribute to Regulatory departmental SOPs

Required Qualifications

  • University degree in science, engineering, and/or biotechnology
  • At least 5 years of experience in Regulatory Affairs in the pharmaceutical industry
  • Working knowledge of FDA regulations and FDA/ICH guidelines pertaining to CMC submissions, in particular FDA guidance applying to Biologics
  • In depth understanding and prior experience with CMC submissions for adoptive T-cell therapy in pharmaceutical industry or academic center
  • Meticulous attention to detail
  • Ability to self-manage and organize a high workload.
  • Strong technical writing skills

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

Application Process

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.

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