Director, Regulatory Affairs - Immunology & Inflammation

1w1 week ago

Nurix Therapeutics

Full-time · $250,000 – $350,000

About this role

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on targeted protein degradation medicines for cancer and inflammatory diseases. Powered by AI-integrated discovery and ligase expertise, it advances degrader-based treatments. The Director, Regulatory Affairs (Strategy, I&I) serves as global regulatory lead for immunology and inflammation.

This role develops global regulatory strategy with internal stakeholders and implements tactics for compliant nonclinical and clinical submissions. It supports early development, registration, and life cycle management activities. Cross-functional collaboration ensures regulatory filings meet company timelines.

The position works with regulatory affairs, clinical development, SVP Head of Regulatory Affairs, team leaders, and CROs. It represents Regulatory Affairs on development teams. Based on-site in the Brisbane, CA office, it adheres to regulations and SOPs.

Leads high-quality submissions like INDs, CTAs, NDAs, MAAs and Health Authority interactions with FDA and EMA. Anticipates risks, provides mitigation guidance, and plans long-term strategies. Accelerates clinical development and regulatory approval.

Requirements

Experience serving as global regulatory lead for immunology and inflammation therapeutic areas
Expertise in developing regulatory strategies and preparing IND, CTA, NDA, and MAA submissions
Proven ability to lead interactions and meetings with FDA, EMA, and other Health Authorities
Strong knowledge of nonclinical and clinical regulatory requirements in biopharmaceutical development
Ability to assess regulatory risks based on regulatory precedence and provide strategic guidance
Familiarity with guidelines for innovative modalities like targeted protein degradation
Cross-functional collaboration skills with clinical development and CROs

Responsibilities

Develop and implement competitive and effective global clinical and nonclinical regulatory strategies for immunology and inflammation indications
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
Lead communication with global Health Authorities such as FDA and EMA, including planning and preparing for formal meetings
Develop and execute global regulatory strategy for long-term planning, including expedited development needs
Anticipate issues and guide cross-functional teams on risk mitigation strategies for development challenges
Ensure adherence to current regulations associated with regulatory activities
Work strategically with regulatory functions to develop detailed actionable submission plans and track deliverables