Head of Regulatory Affairs, Hematology & Oncology

Rigel Pharmaceuticals, Inc.; South San Francisco (CA); Hybrid; USD 335,000 - 380,000; Full time

Job summary

Rigel Pharmaceuticals, Inc. seeks a strategic Vice President of Regulatory Affairs to lead regulatory strategy across clinical development and commercial portfolios in hematology and oncology.

The role partners with Legal, Medical Affairs, CMC, and Quality to ensure compliant submissions and lifecycle management. The leader will oversee interactions with FDA and other health authorities, manage internal regulatory personnel and external service providers, and shape labeling, promotion, and

Qualifications

• Bachelor’s degree in a life sciences or related discipline.
• Advanced degree is preferred.
• 15+ years in pharmaceutical/biotech with at least 10 years in Regulatory Affairs.

Responsibilities

• Lead registrational and regulatory strategy for investigational agents and marketed products.
• Oversee preparation and submission of INDs, NDAs, and related filings.
• Manage interactions with FDA and other health authorities.
• Provide regulatory guidance for promotional materials and labeling.
• Lead regulatory team and manage external providers.

Skills

Regulatory leadership

FDA interactions

Advertising review

Cross-functional leadership

Labeling

Strategic planning

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Rigel Pharmaceuticals, Inc. seeks a strategic Vice President of Regulatory Affairs to lead regulatory strategy across clinical development and commercial portfolios in hematology and oncology.

The role partners with Legal, Medical Affairs, CMC, and Quality to ensure compliant submissions and lifecycle management. The leader will oversee interactions with FDA and other health authorities, manage internal regulatory personnel and external service providers, and shape labeling, promotion, and