Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)
$232,000–$274,000 year
On-siteBrisbane, California, United States
Job Summary
Develop a comprehensive global regulatory strategy for oncology solid tumors, driving product development, registration, and labeling while managing risks and mitigation plans. Lead the preparation of high-quality submissions including INDs, CTAs, NDAs, and MAAs, ensuring adherence to FDA, EMA, and ICH guidelines. Represent Regulatory Affairs on cross-functional teams, facilitate agency interactions, and define actionable submission plans to accelerate clinical development. Manage consultants, track major deliverables, and implement systems for document and regulatory information management. This role supports life cycle management activities within Nurix Therapeutics' Regulatory team in Brisbane, CA, requiring 12+ years of experience in regulatory strategy and oncology.
Required Qualifications
- Bachelor's degree in life-sciences or related scientific discipline
- Minimum of 12 years in Regulatory affairs strategy
- Significant experience in the oncology (solid tumors) therapeutic area
- Knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Project management and critical thinking skills
- Ability to work independently as well as part of a team environment
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others
- Location: Brisbane, CA (Onsite role)
Desired Qualifications
- Advanced degree
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