Director, Global Regulatory Strategy – Immunology & Inflammation

Nurix

Brisbane (CA)

On-site

USD 220,000 - 254,000

Full time

14 days+

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Benefits offered by this job

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Job summary

Nurix Therapeutics is seeking a Director, Regulatory Affairs (Strategy, Immunology and Inflammation) to lead global regulatory strategy for the immunology/inflammation area. The role requires extensive experience in regulatory submissions (INDs, CTAs, NDAs, MAAs) and interactions with global health authorities, working cross-functionally to drive early development through life-cycle management.

The position is on-site at the Brisbane, CA office, with a focus on strategic leadership and

Qualifications

  • Bachelor's degree in life-sciences or related field; advanced degree preferred.
  • At least 12 years in Regulatory Affairs strategy with immunology/inflammation focus.
  • Strong knowledge of FDA, EMA and ICH guidelines and regulations.
  • Experience supporting planning and execution of major filings to health authorities.

Responsibilities

  • Develop global regulatory strategies for immunology and inflammation indications.
  • Lead preparation of high-quality global submissions (IND, CTAs, NDAs, MAAs).
  • Interact with Health Authorities (FDA/EMA) and plan formal meetings.
  • Collaborate cross-functionally to deliver submission plans and timelines.
  • Manage consultants and cross-functional teams to drive regulatory programs.

Skills

Regulatory strategy
FDA/EMA knowledge
IND/CTA/NDAs/MAAs submissions
Cross-functional collaboration
Project management
Communication
Team leadership
Immunology & Inflammation

Education

Bachelor’s in life-sciences
Advanced degree preferred

Tools

MS Project
Smartsheet
Excel

Job description

Nurix Therapeutics is seeking a Director, Regulatory Affairs (Strategy, Immunology and Inflammation) to lead global regulatory strategy for the immunology/inflammation area. The role requires extensive experience in regulatory submissions (INDs, CTAs, NDAs, MAAs) and interactions with global health authorities, working cross-functionally to drive early development through life-cycle management.

The position is on-site at the Brisbane, CA office, with a focus on strategic leadership and

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