VP, Regulatory Affairs — Global Strategy & FDA Leadership

Warman O'Brien; San Francisco (CA); Hybrid; USD 320,000 - 520,000; Full time

Job summary

Warman O'Brien in the San Francisco Bay Area is seeking a VP of Regulatory Affairs to set and drive global regulatory strategy across development programs. You will lead FDA interactions, prepare regulatory submissions, and influence cross-functional teams to advance the pipeline.

The role requires senior regulatory leadership, a track record of successful FDA engagements, and strategic, commercially aware thinking.

Qualifications

• Extensive Regulatory Affairs leadership experience within biotech or pharmaceutical development.
• Strong track record of developing regulatory strategies and leading FDA interactions.
• Experience with peptides and/or small molecules is highly desirable.
• Therapeutic experience in metabolic diseases and/or immunology is preferred.

Responsibilities

• Lead and execute global regulatory strategy across clinical development programs.
• Drive FDA and other health authority interactions, including regulatory meetings and submissions.
• Provide strategic regulatory guidance to clinical development teams and senior leadership.
• Collaborate with internal stakeholders and external experts to support development milestones.
• Identify regulatory risks and opportunities to optimize development pathways.

Skills

Regulatory leadership

FDA interactions

Clinical development

Cross-functional leadership

Job description

Warman O'Brien in the San Francisco Bay Area is seeking a VP of Regulatory Affairs to set and drive global regulatory strategy across development programs. You will lead FDA interactions, prepare regulatory submissions, and influence cross-functional teams to advance the pipeline.

The role requires senior regulatory leadership, a track record of successful FDA engagements, and strategic, commercially aware thinking.