BridgeBio · 1 week ago
VP, Regulatory Affairs, Strategy, Labeling and Operations
San Francisco, CA
Full-time
Hybrid
Director/Executive
$345K/yr - $400K/yr
15+ years expBridgeBio is a pioneering biotechnology company focused on developing life-changing medicines for rare diseases. The Vice President of Regulatory Affairs will oversee the Regulatory Operations and Labeling functions, managing a team of experts to ensure compliance and strategic alignment across all regulatory activities.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
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
Qualification
Required
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
Benefits
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
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 where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.35BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
2024-01-18Post Ipo Debt· $1.25B
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
2026-01-05
2025-12-24
Company data provided by crunchbase