Head of Global Regulatory Strategy - Late-Stage Oncology

Precision Point; San Francisco (CA); On-site; USD 350,000 - 550,000; Full time

Job summary

Precision Point is partnering with a late-stage biotech focused on oncology and autoimmune indications to advance regulatory strategy and submissions. The role leads global regulatory strategy from End of Phase II through BLA, oversees FDA meetings and EMA interactions, and guides Phase III design and labeling efforts to enable a successful commercial launch.

You'll own BLA planning, timelines, and responses, drive expedited pathways where appropriate, mentor the regulatory team, and partner

Qualifications

• Phase III regulatory strategy leadership for at least one product through approval and commercial launch.
• 15+ years regulatory affairs experience with senior leadership roles.
• Direct ownership of BLA/NDA submission and labeling negotiations.
• Experience leading End of Phase II, Pre BLA/NDA, and FDA meetings.
• Experience in oncology, hematology, or large molecule biologics.
• Global regulatory experience including EMA submissions and interactions.
• Strong executive presence with clear communication of regulatory risk to leadership.
• Bachelor's degree in a scientific discipline.

Responsibilities

• Define and lead global regulatory strategy from End of Phase II through BLA submission, approval and launch.
• Lead End of Phase II, Pre BLA and other key FDA meetings, and direct EMA interactions.
• Shape Phase III and pivotal trial design with clinical development to support registration and labeling goals.
• Own BLA planning and execution, including submission strategy and responses to health authority questions.
• Lead labeling strategy and collaborations on launch readiness and post-approval commitments.
• Evaluate expedited pathways such as Breakthrough Therapy, Fast Track, Accelerated Approval, Priority Review and PRIME.
• Assess regulatory risk and present strategy and probability of success to leadership and the board.
• Serve as regulatory lead on programs, supporting alliances and business development diligence.
• Build and mentor the regulatory team as the company grows toward commercial stage.

Skills

Regulatory strategy

Executive leadership

Global regulatory experience

Clear communication

Phase III leadership

Education

Bachelor's degree in science

Advanced scientific degree preferred (PharmD/PhD)

Job description

Precision Point is partnering with a late-stage biotech focused on oncology and autoimmune indications to advance regulatory strategy and submissions. The role leads global regulatory strategy from End of Phase II through BLA, oversees FDA meetings and EMA interactions, and guides Phase III design and labeling efforts to enable a successful commercial launch.

You'll own BLA planning, timelines, and responses, drive expedited pathways where appropriate, mentor the regulatory team, and partner