Strategic Regulatory Affairs Lead – Oncology

Nurix, Inc.; California; Hybride; USD 188 000 - 231 000; Plein temps

Résumé du poste

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager/Associate Director for Regulatory Affairs (Strategy, Hematology Oncology). You will lead global regulatory strategy and interact with health authorities to advance development programs and future marketing applications.

The role requires 8+ years in regulatory affairs strategy, deep knowledge of FDA/EMA/ICH guidelines, and strong cross-functional collaboration across development teams.

Qualifications

• Bachelor's degree in life sciences or related field
• Minimum 8 years in Regulatory affairs strategy
• Strong knowledge of FDA/EMA/ICH guidelines

Responsabilités

• Provide regulatory strategic direction for global development programs
• Design and implement regulatory strategies for INDs, CTAs, NDAs
• Interact with health authorities and prepare meetings
• Maintain and monitor regulatory submissions and documents
• Collaborate with cross-functional teams across development lifecycles

Connaissances

Regulatory strategy

FDA knowledge

EMA knowledge

ICH guidelines

Project management

Cross-functional collaboration

Formation

Bachelor's degree in life sciences

Advanced degree preferred

Description du poste

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager/Associate Director for Regulatory Affairs (Strategy, Hematology Oncology). You will lead global regulatory strategy and interact with health authorities to advance development programs and future marketing applications.

The role requires 8+ years in regulatory affairs strategy, deep knowledge of FDA/EMA/ICH guidelines, and strong cross-functional collaboration across development teams.