Senior CMC Regulatory Strategist — Small Molecules

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

Job summary

Nurix Therapeutics seeks an experienced CMC Regulatory professional to shape global regulatory strategies and lead Module 3 content across small molecule programs. You will influence cross-functional teams, own submission timelines, and mentor junior staff, with Senior Associate Director level growth and strategic ownership.

You will author and review CMC Module 3 content for IND/IMPD filings, assess changes affecting regulatory filings, and ensure compliance with ICH, FDA, EMA requirements

Qualifications

• Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or related life sciences required.
• Minimum 6+ years in regulatory affairs with substantial focus on CMC and 10+ years total pharma/biotech experience.
• Experience authoring/compiling CMC (Module 3) content for regulatory submissions for small molecule products.

Responsibilities

• Develop, communicate, and execute global CMC regulatory strategies for drug substance and drug product across product lifecycle.
• Author, review, and compile high-quality CMC Module 3 content for regulatory submissions (IND/IMPD and global filings).
• Assess regulatory impact of manufacturing, analytical, formulation, and supply chain changes; recommend filing strategies.
• Provide proactive CMC regulatory guidance and risk assessment to development, ops, and commercial teams.
• Represent CMC Regulatory on cross-functional teams; manage submission timelines and deliverables.
• Ensure submission content is accurate, consistent, and compliant with ICH, FDA, EMA and other markets.
• Oversee QA processes to ensure regulatory standards; mentor junior staff where applicable.

Skills

CMC regulatory strategies

Regulatory submissions

Module 3 content authoring

Cross-functional collaboration

Regulatory guidance

Mentoring junior staff

Education

Bachelor's degree in life sciences

Advanced degree preferred (MS/PhD/PharmD)

Job description

Nurix Therapeutics seeks an experienced CMC Regulatory professional to shape global regulatory strategies and lead Module 3 content across small molecule programs. You will influence cross-functional teams, own submission timelines, and mentor junior staff, with Senior Associate Director level growth and strategic ownership.

You will author and review CMC Module 3 content for IND/IMPD filings, assess changes affecting regulatory filings, and ensure compliance with ICH, FDA, EMA requirements