CMC Regulatory Lead - Small Molecules (Assoc. Director)

Nurix Therapeutics; Brisbane (CA); Presencial; USD 188.000 - 209.000; Jornada completa

Descripción de la vacante

Nurix Therapeutics is seeking an Associate Director-level Regulatory Affairs CMC to shape the regulatory path for our small molecule portfolio from development through lifecycle. You will author Module 3 content, guide global submissions, and mentor junior staff while partnering with operations, QA, manufacturing, and CMOs.

This onsite Brisbane, CA role emphasizes cross-functional leadership, strategic influence, and staying current with ICH and FDA/EMA requirements to drive timely filings.

Formación

• Bachelor's degree in chemistry, pharmacy, pharmaceutical sciences, chemical engineering, or life sciences.

Responsabilidades

• Author, review, and compile CMC Module 3 content for regulatory submissions.
• Develop and execute global CMC regulatory strategies across product lifecycle.
• Provide regulatory guidance and risk assessment to cross-functional teams.

Conocimientos

CMC regulatory

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Technical writing

Educación

Bachelor's degree in chemistry or life sciences

Advanced degree preferred

Descripción del empleo

Nurix Therapeutics is seeking an Associate Director-level Regulatory Affairs CMC to shape the regulatory path for our small molecule portfolio from development through lifecycle. You will author Module 3 content, guide global submissions, and mentor junior staff while partnering with operations, QA, manufacturing, and CMOs.

This onsite Brisbane, CA role emphasizes cross-functional leadership, strategic influence, and staying current with ICH and FDA/EMA requirements to drive timely filings.