VP, Regulatory Operations and Labeling

Role Summary

The Vice President, Regulatory Operations and Labeling will oversee BridgeBio’s Operations and Labeling functions, and will also support regulatory strategy as needed. This leader will manage a team of subject matter experts and leaders responsible for Regulatory Operations, Regulatory Business Operations, and Labeling, ensuring excellence, compliance, and strategic alignment across all regulatory activities. The VP will ensure the organization has the right infrastructure, technology, and governance to support global submissions, and compliant labeling, while integrating advanced capabilities such as artificial intelligence to drive efficiency and insight. The ideal candidate brings broad regulatory expertise spanning for both development and commercial products, labeling, and operations, combined with understanding and experience in regulatory affairs, and the ability to lead in a fast-paced, entrepreneurial environment.

Responsibilities

• Provide overarching leadership and strategic direction for the Regulatory Operations, Regulatory Business Operations, and Labeling, each led by experienced subject matter experts and team leaders
• Partner with the Chief Regulatory Officer and Regulatory Leaders to ensure alignment of operational strategy with regulatory goals
• Foster an infrastructure that enables innovation, speed, and accountability within and across the regulatory organization
• Lead the integration of artificial intelligence and advanced digital tools across systems and processes to enhance productivity, compliance, and decision-making
• Establish and maintain the framework for regulatory SOPs, work instructions, and desk procedures to ensure consistency, compliance, and clarity
• Lead and develop a team of team leaders and subject matter experts, fostering a collaborative and high-performance culture
• Ensure effective resource planning, talent development, and staff augmentation as needed to support corporate priorities
• Promote continuous learning and professional development within the broader regulatory organization

Where You'll Work

This is a hybrid role based either in San Francisco, or Washington, D.C. Remote will also be considered.

Who You Are

• Advanced degree in a scientific discipline (PharmD, PhD, MD, or MS) required.
• 15+ years of progressive regulatory experience in the biopharmaceutical industry, including leadership of multidisciplinary regulatory teams.
• Proven experience in labeling strategy and operations for development and commercial products, with deep understanding of global submission requirements and post-approval obligations.
• Demonstrated expertise in establishing and managing regulatory systems (e.g., Veeva Vault, RIM) and process governance frameworks (SOPs, WIs, desk procedures).
• Strong working knowledge of clinical and nonclinical regulatory strategy and interactions with global health authorities.
• Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions.
• Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment.