Senior Regulatory Strategy Lead, Hematology/Oncology

NURIX; San Francisco (CA); On-site; USD 188,000 - 231,000; Full time

Job summary

Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation medicines. Brisbane, CA onsite, seeks an experienced Senior Manager/Associate Director of Regulatory Affairs to lead global regulatory strategy and submissions for hematology/oncology programs.

You will work closely with Regulatory, Clinical, and Development teams to shape indications, filings, and lifecycle plans, ensuring compliance with FDA/EMA guidelines and ICH standards.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Minimum 8 years in regulatory affairs strategy.
• Strong knowledge of FDA, EMA and ICH guidelines.
• Experience planning clinical trial and marketing applications to health authorities.
• Ability to interpret scientific and regulatory information.
• Excellent written and verbal communication; present to senior management.
• Proven track record in regulatory submissions and lifecycle management.

Responsibilities

• Provide regulatory strategic direction for global development programs.
• Assist regulatory staff with development program activities and deliverables.
• Design regulatory strategies to obtain and maintain INDs, CTAs, NDAs and lifecycle management.
• Act as regulatory representative on clinical studies and ensure compliant execution.
• Collaborate with cross-functional teams to ensure lifecycle compliance.
• Maintain submissions and health authority communications; track major deliverables.
• Oversee document management, submission content planning, and regulatory information management.
• Manage consultants and contractors as needed.

Skills

Regulatory strategy

FDA/EMA/ICH knowledge

Clinical development understanding

Project management

Regulatory submissions planning

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in life-sciences

Advanced degree preferred

Tools

MS Project

Smartsheet

Excel

Job description

Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation medicines. Brisbane, CA onsite, seeks an experienced Senior Manager/Associate Director of Regulatory Affairs to lead global regulatory strategy and submissions for hematology/oncology programs.

You will work closely with Regulatory, Clinical, and Development teams to shape indications, filings, and lifecycle plans, ensuring compliance with FDA/EMA guidelines and ICH standards.