BridgeBio Pharma

BridgeBio Pharma

Reg Affairs Assoc. Director

Remote - USA · Director

Sponsorship not specifiedDetected 9 days ago
SpringA/B TestingComplianceFDA RegulatoryResearchLeadershipCommunicationMentoringAdaptability

About the role

  • Mavericks Wanted When was the last time you achieved the impossible?
  • Together we define white space, push boundaries, and empower people to solve problems.
  • Together, we'll ask "why not?" and help reengineer the future of biopharma.

Responsibilities

  • Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).
  • Support advisory boards, speaker programs, and field training materials as needed.
  • Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.
  • Support development of core claims documents and messaging frameworks.
  • Support responses to OPDP inquiries or regulatory questions related to promotional materials.
  • 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.

Requirements

  • Advanced scientific degree (PharmD, PhD, MD) or equivalent.
  • Experience supporting commercial launches and/or late-stage development programs.
  • Demonstrated ability to influence cross-functional stakeholders in a matrixed environment.
  • Experience in rare disease or specialty therapeutics.
  • You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies

Nice to have

  • 8+ years of pharmaceutical experience with 5+ years plus relevant ad promo experience

Compensation

  • Market leading compensation

Benefits

  • Employee stock purchase program
  • Pre-tax commuter benefits
  • 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)
  • 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
  • We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
  • At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.

Company info

  • 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

This listing is sourced directly from BridgeBio Pharma's careers page and normalized into a canonical job model.