Senior Regulatory Affairs CMC Lead - Small Molecules

Nurix Therapeutics; United States; 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 global CMC regulatory path across the product lifecycle. You will author Module 3 content and influence strategy as the CMC regulatory voice on cross-functional teams.

The role offers hands-on content development for regulatory submissions (IND/IMPD and global filings) and mentorship of junior staff, with opportunities to take greater strategic ownership at the Associate

Qualifications

• Bachelor’s degree in chemistry, pharmacy, pharmaceutical sciences or related life sciences; an advanced degree preferred.
• Minimum 6+ years in regulatory affairs with a focus on CMC; 10+ years overall in pharma/biotech.
• Experience authoring CMC Module 3 content for regulatory submissions for small molecules.
• Working knowledge of ICH guidelines and FDA/EMA CMC requirements.

Responsibilities

• Author, review, and compile CMC (Module 3) content for submissions (IND/IMPD, filings).
• Assess regulatory impact of changes in manufacturing, analytics, and formulation.
• Provide proactive CMC guidance to development, operations, and commercial teams.
• Collaborate with Manufacturing, Analytical Development, QA, Supply Chain, and CMOs/CDMOs.
• Manage submission timelines and deliverables with regulatory operations.

Skills

Regulatory affairs expertise

CMC knowledge

Cross-functional collaboration

Project management

Technical writing

Education

Bachelor's degree in chemistry or life sciences

Advanced degree (M.S./Ph.D./ Pharm.D.) preferred

Job description

Nurix Therapeutics is seeking a Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules) to shape the global CMC regulatory path across the product lifecycle. You will author Module 3 content and influence strategy as the CMC regulatory voice on cross-functional teams.

The role offers hands-on content development for regulatory submissions (IND/IMPD and global filings) and mentorship of junior staff, with opportunities to take greater strategic ownership at the Associate