Global Regulatory Strategy Leader - Hematology/Oncology

Nurix Therapeutics; Brisbane (CA); On-site; USD 188,000 - 231,000; Full time

Job summary

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager / Associate Director of Regulatory Affairs (Strategy, Hematology Oncology) to help shape global regulatory strategy and programs for development and future marketing of cancer therapies. You will collaborate across functions to design submission plans and ensure lifecycle management.

The role requires deep knowledge of FDA/EMA guidelines, strong project management, and ability to interact with health authorities.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Minimum 8 years in regulatory affairs strategy.
• Strong knowledge of FDA, EMA, ICH guidelines and regulations.
• Experience planning clinical trial and marketing applications to health authorities.

Responsibilities

• Provide regulatory strategic direction for global development programs.
• Design and implement regulatory strategies to obtain and maintain regulatory approvals.
• Act as regulatory representative on clinical studies and ensure compliant trial execution.
• Interact with health authorities and prepare meetings and submissions.
• Maintain submission plans, health authority communications, and lifecycle management.

Skills

Regulatory strategy

Regulatory submissions planning

FDA/EMA guidance

Clinical trial planning

Regulatory communications

Cross-functional collaboration

Project management

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

MS Project

Smartsheet

Excel

Job description

Nurix Therapeutics in Brisbane, CA is seeking a Senior Manager / Associate Director of Regulatory Affairs (Strategy, Hematology Oncology) to help shape global regulatory strategy and programs for development and future marketing of cancer therapies. You will collaborate across functions to design submission plans and ensure lifecycle management.

The role requires deep knowledge of FDA/EMA guidelines, strong project management, and ability to interact with health authorities.