VP, Regulatory Affairs, Strategy, Labeling and Operations

Responsibilities

• 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 previous broad global 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. #LI-TC1
• Strategic & Functional Leadership
• 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.

Requirements

• 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.
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.
• Rewarding Those Who Make the Mission Possible
• We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
• Financial Benefits:
• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Health & Wellbeing:
• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in w

Benefits

Additional Information

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

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