Director, Regulatory Strategy – Immunology & Inflammation

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

Job summary

Nurix Therapeutics in Brisbane, CA is seeking a Director, Regulatory Affairs (Strategy, I&I) to lead global regulatory strategies for immunology/inflammation programs. You will drive submissions (IND/CTAs/NDAs/MAAs), manage regulatory timelines, and interact with agencies like FDA/EMA in collaboration with cross-functional teams.

The role requires deep regulatory expertise, strong project management, and the ability to guide development programs through early and late-stage life cycle

Qualifications

• Bachelor or higher in life-sciences; advanced degree preferred.
• Extensive experience in regulatory strategy for immunology/inflammation.
• Strong track record of global submissions and HA interactions.

Responsibilities

• Develop global regulatory strategies for immunology/inflammation indications.
• Lead preparation of high-quality regulatory submissions (IND/CTAs/NDAs/MAAs).
• Interact with FDA/EMA and other health authorities and manage cross-functional teams.

Skills

Regulatory Strategy

FDA/EMA knowledge

IND/CTA/MAA submissions

Cross-functional collaboration

Project management

Education

Bachelor's in life-sciences

Advanced degree preferred

Tools

MS Project

Smartsheet

Excel trackers

Job description

Nurix Therapeutics in Brisbane, CA is seeking a Director, Regulatory Affairs (Strategy, I&I) to lead global regulatory strategies for immunology/inflammation programs. You will drive submissions (IND/CTAs/NDAs/MAAs), manage regulatory timelines, and interact with agencies like FDA/EMA in collaboration with cross-functional teams.

The role requires deep regulatory expertise, strong project management, and the ability to guide development programs through early and late-stage life cycle