Director, Regulatory Strategy - Immunology & Inflammation

BioSpace; Brisbane (CA); On-site; USD 220,000 - 254,000; Full time

Job summary

Nurix Therapeutics seeks a Director, Regulatory Affairs (Strategy, AID) to join the Brisbane, CA Regulatory team. You will serve as the global regulatory lead for immunology and inflammation, developing the global regulatory strategy and guiding submissions and agency interactions for early development, registration, and lifecycle management.

This on-site role requires cross-functional collaboration with development teams to ensure compliance and timely filings, leveraging strong leadership and

Qualifications

• Bachelor's degree in life-sciences or related discipline; advanced degree preferred.
• Minimum of 12 years in Regulatory affairs strategy with immunology/inflammation experience.
• Strong knowledge of FDA, EMA and ICH guidelines and regulations.
• Experience planning clinical trial and marketing applications with health authorities like FDA/EMA.
• Proven track record in planning and executing major regulatory filings.
• Excellent organizational and communication skills; able to work independently and in a team.

Responsibilities

• Develop and implement global regulatory strategies for immunology and inflammation indications.
• Collaborate with cross-functional teams and CROs to execute development strategies.
• Lead and manage preparation of high-quality global submissions (INDs, CTAs, NDAs, MAAs).
• Engage with Health Authorities (FDA/EMA) and prepare for formal meetings.

Skills

Regulatory strategy

FDA/EMA/ICH knowledge

Regulatory submissions

Cross-functional collaboration

Project management

Regulatory communications

Regulatory operations tools

Education

Bachelor's degree in life-sciences or related

Advanced degree preferred

Tools

MS Project

Smartsheet

Excel trackers

Job description

Nurix Therapeutics seeks a Director, Regulatory Affairs (Strategy, AID) to join the Brisbane, CA Regulatory team. You will serve as the global regulatory lead for immunology and inflammation, developing the global regulatory strategy and guiding submissions and agency interactions for early development, registration, and lifecycle management.

This on-site role requires cross-functional collaboration with development teams to ensure compliance and timely filings, leveraging strong leadership and