Director, Regulatory Affairs

Location
San Francisco, CA, United States
Posted
Jul 31, 2021
Ref
5433351002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

Position

The director of regulatory affairs will develop and execute strategies for submissions across multiple projects, in line with corporate priorities. The position provides guidance to the cross functional teams for content requirements and compliance with regulations across CMC, nonclinical, and clinical areas. The position supports the regulatory team and actively contributes to all IND and CTA submission activities, including submission management. The position develops and maintains Regulatory procedures.

Key responsibilities
  • Develop and maintain submission content plans, track documents from authoring to approval
  • Provide operational oversight for all phases of applications to regulatory authorities
  • Manage pre- and post-submission activities, IND, CTA submissions, briefing packages, amendments, and future NDAs/BLAs
  • Implement project management control and tracking
  • In collaboration with team, perform/manage critical analyses of GXP related data
  • Lead, coordinate, write, critically review, and provide input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, Investigator's Brochure,
    IMPD, DSUR, clinical study reports)
  • Facilitate activities to ensure prioritized objectives are successfully delivered, including team preparation for meetings with FDA, EMA, and other regulatory authorities.
  • Facilitate Regulatory Authority communications/interactions.
  • Interface with global regulatory authorities and consultants as needed
  • Maintain a strong working knowledge of US, EU, and ICH regulatory requirements in relevant geographies; ability to apply knowledge both strategically and operationally to support corporate goals.
  • Oversee and ensure compliance with regulatory procedures and work practices
  • Oversee maintenance and process improvements for internal regulatory documentation and archival systems
  • Train, mentor and supervise regulatory employees in Regulatory Affairs

Requirements
  • Advanced degree in life sciences
  • 8 years of regulatory experience
  • Extensive knowledge of global submission standards (FDA, EMA, etc.)
  • Thorough knowledge of ICH and GCP requirements
  • Experience in the development of regulatory strategy, and in various phases of the drug development cycle
  • Proven ability to organize and oversee regulatory submissions; plan and execute a high workload with a small team.
  • Oncology experience is a plus
  • Ethical mindset, team player