CMC Regulatory Lead, Small Molecules – Submissions

Regulatory Jobs; Brisbane (CA); On-site; USD 188,000 - 209,000; Full time

Job summary

Nurix Therapeutics is seeking a Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) to shape the CMC regulatory path from clinical development through marketed lifecycle.

You will author Module 3 content, influence regulatory strategy, and mentor junior staff while collaborating with cross-functional teams to ensure regulatory compliance across FDA, EMA, and global markets.

Qualifications

• Minimum 6+ years in regulatory affairs with a substantial focus on CMC
• 10+ years of overall pharmaceutical/biotech industry experience
• Experience authoring CMC (Module 3) content for regulatory submissions for small molecules
• Working knowledge of ICH guidelines and FDA/EMA CMC requirements
• Strong written communication and scientific writing skills
• Ability to manage multiple projects with attention to detail

Responsibilities

• Develop, communicate, and execute global CMC regulatory strategies for assigned programs across the product lifecycle
• Author, review, and compile high-quality CMC content for regulatory submissions (IND/IMPD and global filings)
• Assess regulatory impact of manufacturing, analytical, formulation, and supply chain changes
• Provide proactive CMC regulatory guidance to development, operations, and commercial teams
• Represent CMC Regulatory on project teams and manage submission timelines and deliverables

Skills

CMC regulatory knowledge

Regulatory submissions drafting

Cross-functional collaboration

Project management

Education

Bachelor's degree in chemistry or life sciences

Job description

Nurix Therapeutics is seeking a Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) to shape the CMC regulatory path from clinical development through marketed lifecycle.

You will author Module 3 content, influence regulatory strategy, and mentor junior staff while collaborating with cross-functional teams to ensure regulatory compliance across FDA, EMA, and global markets.