BridgeBio logo
BridgeBio

Hope Through Rigorous Science

Regulatory Affairs Director

DirectorDirectorFull TimeRemoteLeadTeam 201-500Since 2015H1B SponsorCompany SiteLinkedIn

Location

California

Posted

2 days ago

Salary

$230K - $285K / year

Seniority

Lead

Postgraduate Degree8 yrs expEnglish

Job Description

Regulatory Affairs Director

BridgeBio

• 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.

Job Requirements

  • 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

  • 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

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