Senior Regulatory Affairs Associate

Location
San Francisco, CA, United States
Posted
Sep 30, 2020
Ref
4895034002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Nurix was founded by internationally recognized experts in the ubiquitin-proteasome (UPS) field and received its initial funding from leading life science investors Third Rock Ventures and The Column Group. Nurix recently entered into a multi-year collaboration with Gilead and Sanofi focused on developing bi-functional molecules to degrade protein targets as novel therapeutics. Additionally, Nurix has a strong internal drug discovery pipeline focused on oncology, immunology and inflammation. Nurix plans to advance two molecules into clinical trials in early 2021.

Position

We are seeking to hire a Senior Regulatory Affairs Associate who will be responsible for the preparation and maintenance of regulatory submissions to FDA and other Regulatory Agencies. The incumbent will lead meetings with CMC, nonclinical, and clinical team members to develop IND and CTA plans and execute according to corporate objectives. The candidate will contribute to writing IND submission components, IMPDs for CTAs and application forms. The candidate will build INDs and CTAs and be responsible for maintaining regulatory applications in compliance with applicable guidance and regulations.

Key responsibilities:
  • Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions
  • Conduct regulatory review of submission documents
  • Coordinate document workstream with external publishing group
  • Represent Regulatory Affairs on cross-functional teams and provide regulatory guidance
  • Lead preparation of IND annual reports/DSUR and contribute to authoring
  • Prepare IND amendments (e.g. monthly clinical site packages)
  • Develop and maintain regulatory knowledge and advise on changing regulatory requirements
  • Track and execute on commitments from Regulatory Agency submissions and/or Agency Feedback
  • Manage and maintain regulatory archive
  • Develop regulatory SOPs

Education/skills requirements:
  • University degree in biology, biochemistry, immunology, microbiology, biotechnology, or similar disciplines
  • Five or more years of experience in Regulatory Affairs in the pharmaceutical industry
  • Experience working on IND submissions
  • Familiar with FDA regulations and FDA/ICH guidelines
  • Working knowledge of regulatory compliance for essential clinical site documents and proven practical experience in preparing investigator information for FDA submission.
  • Experience with ex-US regulations and practical experience in preparing CTAs
  • Meticulous attention to detail
  • Ability to self-manage varying workloads across several programs
  • Strong interpersonal and communication 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.