Regulatory Affairs Director

BridgeBio

Associate Director/Director providing regulatory leadership for promotional materials at BridgeBio Pharma. Responsible for compliance with FDA regulations and enabling effective communication across programs.

Posted 7/9/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $230,000 - $285,000 per yearWebsite

About the role

Key responsibilities & impact

Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).
Provide proactive guidance on promotional strategy, claims development, and risk positioning.
Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.
Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.
Assess regulatory risk and recommend clear, practical mitigation strategies.
Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).
Ensure materials are accurate, balanced, and supported by substantial evidence.
Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns.
Support advisory boards, speaker programs, and field training materials as needed.
Contribute to development and refinement of internal SOPs and review processes.
Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.
Anticipate labeling implications for promotional planning, especially during launch readiness.
Support development of core claims documents and messaging frameworks.
Monitor FDA enforcement actions and emerging trends.
Support responses to OPDP inquiries or regulatory questions related to promotional materials.
Contribute to inspection readiness activities related to promotional review processes.

Requirements

What you’ll need

Advanced scientific degree (PharmD, PhD, MD) or equivalent.
8+ years of pharmaceutical experience with 5+ years plus relevant ad promo experience
Deep understanding of FDA promotional regulations, OPDP expectations, and relevant guidance documents.
Experience supporting commercial launches and/or late-stage development programs.
Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.

Benefits

Comp & perks

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Claims DevelopmentPromotional StrategyRegulatory ReviewSOP DevelopmentLaunch ReadinessCore Claims Document DevelopmentDigital Content StrategyEvidence-Based Material SupportInspection ReadinessCommercial Launch Support

Soft Skills

Influencing StakeholdersStrategic Direction

Certifications

Advanced Scientific Degree