Senior 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, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.

Responsibilities

• Provide regulatory strategic direction and support for assigned global development programs
• Design and implement regulatory strategies to obtain and maintain product investigative and marketing applications
• Act as regulatory representative on early and late phase clinical studies
• Respond to inquiries from global regulatory authorities and prepare/conduct meetings with them
• Assist in the preparation of Annual Reports, DSURs, Investigator’s Brochures, INDs, CTAs, and NDAs
• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
• Monitor and assess regulatory risks and develop mitigation strategies
• Develop detailed, actionable submission plans and track major deliverables
• 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
• Strong knowledge of drug development, FDA, EMA, and ICH guidelines
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities
• Proven track record of supporting major filings and ongoing maintenance of applications
• Proficiency with project management tools such as MS Project, Smartsheet, or Excel
• Excellent organizational, written, and verbal communication skills
• Ability to manage multiple projects and resolve regulatory issues independently