Strategic CMC Regulatory Lead (Small Molecules)

NURIX; San Francisco (CA); Vor Ort; USD 188.000 - 209.000; Vollzeit

Zusammenfassung

Nurix Therapeutics is seeking a Senior Manager / Associate Director of Regulatory Affairs CMC (Small Molecules) in Brisbane, CA. You will shape the CMC regulatory path, author Module 3 content, and influence cross-functional teams across the lifecycle of small molecule programs.

The role requires 6+ years in regulatory affairs with CMC focus and an advanced degree preferred, with strong writing and leadership skills to mentor junior staff and drive regulatory submissions with global teams.

Qualifikationen

• Bachelor’s degree in chemistry or life sciences; advanced degree preferred.
• Minimum 6+ years in regulatory affairs with CMC focus and 10+ years overall in pharma/biotech.
• Demonstrated experience authoring/compiling CMC (Module 3) content for regulatory submissions.
• Working knowledge of ICH quality guidelines and FDA/EMA CMC requirements.

Aufgaben

• Develop, communicate, and execute global CMC regulatory strategies across the product lifecycle.
• Author, review, and compile high-quality CMC content for regulatory submissions (IND/IMPD and global filings).
• Assess regulatory impact of changes and recommend filing strategies and categorization.
• Provide proactive CMC regulatory guidance and mentor junior staff at AD level.

Kenntnisse

CMC Strategy

Regulatory Writing

Cross-functional Leadership

Project Management

Ausbildung

Bachelor’s degree in chemistry or related life sciences

Advanced degree preferred (MS/PhD/PharmD)

Jobbeschreibung

Nurix Therapeutics is seeking a Senior Manager / Associate Director of Regulatory Affairs CMC (Small Molecules) in Brisbane, CA. You will shape the CMC regulatory path, author Module 3 content, and influence cross-functional teams across the lifecycle of small molecule programs.

The role requires 6+ years in regulatory affairs with CMC focus and an advanced degree preferred, with strong writing and leadership skills to mentor junior staff and drive regulatory submissions with global teams.