Senior Director, Global Regulatory Strategy – Oncology

Regulatory Jobs

California

On-site

USD 232,000 - 331,000

Full time

14 days+

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Job summary

Nurix Therapeutics, Inc. is seeking a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team in Brisbane, CA onsite.

The role leads global regulatory strategy development and execution, guiding nonclinical and clinical submissions and interactions with health authorities to support registration and lifecycle management. You will collaborate with the SVP and cross-functional teams, manage high-quality submissions (INDs, CTAs, NDAs, MAAs), and

Qualifications

  • Bachelor's degree in life-sciences or related field; advanced degree preferred.
  • 12+ years in Regulatory affairs strategy with oncology experience.
  • Strong knowledge of FDA/EMA/ICH guidelines and regulations.
  • Experience planning clinical trials and regulatory submissions with health authorities.

Responsibilities

  • Develop a comprehensive regulatory strategy aligned with global requirements.
  • Lead and manage high-quality global submissions (INDs, CTAs, NDAs, MAAs).
  • Represent Regulatory Affairs on cross-functional development teams.
  • Coordinate interactions with FDA, EMA and other health authorities.

Skills

Regulatory strategy
Oncology strategy
Project management
Cross-functional collaboration

Education

Bachelor's degree in life-sciences

Tools

Veeva RIM
Smartsheet
Excel

Job description

Nurix Therapeutics, Inc. is seeking a Director/Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team in Brisbane, CA onsite.

The role leads global regulatory strategy development and execution, guiding nonclinical and clinical submissions and interactions with health authorities to support registration and lifecycle management. You will collaborate with the SVP and cross-functional teams, manage high-quality submissions (INDs, CTAs, NDAs, MAAs), and

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