Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)

The role

This person will develop and execute global CMC regulatory strategies for small molecule programs. They will author Module 3 content and provide regulatory guidance to cross-functional teams.

What you will do

• Develop, communicate, and execute global CMC regulatory strategies for assigned programs
• Author, review, and compile CMC Module 3 content for regulatory submissions
• Assess regulatory impact of manufacturing, analytical, formulation, and supply chain changes
• Provide CMC regulatory guidance and risk assessment to development, technical operations, and commercial teams
• Partner with technical, quality, and supply chain teams to align activities with regulatory requirements
• Represent CMC Regulatory on project and CMC sub-teams
• Manage submission timelines and deliverables
• Ensure submission content is compliant with ICH guidelines and regional requirements
• Contribute to regulatory intelligence by monitoring evolving guidance
• Oversee quality assurance processes to ensure compliance with regulatory standards

Required qualifications

• Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or a related life sciences field
• Minimum 6+ years in regulatory affairs with a substantial focus on CMC
• 10+ years of overall pharmaceutical/biotech industry experience
• Demonstrated experience authoring and/or compiling CMC Module 3 content for small molecule products
• Working knowledge of ICH quality guidelines and of FDA and/or EMA CMC requirements
• Solid understanding of pharmaceutical development, manufacturing processes, and analytical methods for small molecules
• Strong written communication and scientific/technical writing skills
• Ability to manage multiple projects and competing timelines with attention to detail
• Effective cross-functional collaboration and stakeholder management
• Comfort operating with autonomy while escalating appropriately

Nice to have

• Advanced degree (M.S., Ph.D., or Pharm.D.)
• Familiarity with other global regions

About the company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. The company uses an AI-integrated discovery engine to develop treatments for cancer and inflammatory diseases.