Oncology Regulatory Strategy Director (Phase III)

Precision Point; San Francisco (CA); On-site; USD 230,000 - 320,000; Full time

Job summary

Precision Point, a biotechnology company in San Francisco, seeks a Senior Director/Executive Director, Regulatory Affairs Strategy to lead global regulatory activities for oncology programs advancing to Phase III and potential commercialization.

The successful candidate will partner with Clinical Development, Biometrics, Medical Affairs, and executive leadership to define strategies, manage NDA/BLA submissions, and guide interactions with FDA and other authorities, while mentoring the regulatory

Qualifications

• 12+ years of progressive regulatory affairs experience in biotech/pharma
• Experience leading oncology therapeutics development
• Direct NDA/BLA submission experience
• Strong knowledge of FDA regulations and global drug development requirements
• Experience interacting with FDA and global health authorities

Responsibilities

• Develop global regulatory strategies for late-stage oncology programs (Phase III)
• Lead NDA/BLA preparation, submission, and approval
• Serve as primary regulatory strategist for assigned programs
• Lead FDA and health authority meetings and provide guidance to teams
• Translate health authority feedback into integrated development plans
• Oversee regulatory submissions and post-approval commitments
• Collaborate with CMC, Quality, Safety, Medical Writing, and Clinical Operations
• Partner with Medical Affairs, Commercial, and Market Access on strategy and launch readiness
• Mentor regulatory team and build scalable capabilities

Skills

Strategic leadership

Regulatory strategy

Cross-functional collaboration

FDA communications

Education

Bachelor's degree in life sciences/related field

Advanced degree preferred

Job description

Precision Point, a biotechnology company in San Francisco, seeks a Senior Director/Executive Director, Regulatory Affairs Strategy to lead global regulatory activities for oncology programs advancing to Phase III and potential commercialization.

The successful candidate will partner with Clinical Development, Biometrics, Medical Affairs, and executive leadership to define strategies, manage NDA/BLA submissions, and guide interactions with FDA and other authorities, while mentoring the regulatory