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
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