Director, Regulatory Affairs

About the Company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. Powered by a fully AI-integrated discovery engine, Nurix aims to establish degrader-based treatments at the forefront of patient care.

Responsibilities

• Develop and implement competitive global clinical and nonclinical regulatory strategies for immunology and inflammation indications
• Lead and manage the preparation of high-quality global submissions including IND, CTAs, NDAs, and MAAs
• Lead communication and formal meetings with global Health Authorities such as the FDA and EMA
• Represent Regulatory Affairs on assigned cross-functional development teams
• Identify potential regulatory risks and develop mitigation strategies
• Work with cross-functional colleagues and CROs to deliver efficient development strategies and operational plans
• Manage consultants and contractors as needed

Requirements

• Bachelor's degree in life-sciences or related scientific discipline (advanced degree preferred)
• Minimum of 12 years in Regulatory affairs strategy
• Significant experience in the immunology and inflammation therapeutic area
• Strong knowledge of drug development, FDA, EMA, and ICH guidelines
• Proven track record of supporting major filings and marketing applications
• Experience with project management tools such as MS Project, Smartsheet, or Excel trackers
• Excellent organizational, written, and verbal communication skills