BridgeBio Pharma
Reg Affairs Director
Remote - USA · Director · Full-time
Sponsorship not specified$230k-$285kDetected 8 days ago
A/B TestingComplianceFDA RegulatoryResearchLeadershipCommunicationAdaptability
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
- $230,000 - $285,000 USD
- Market-leading compensation
Benefits
- Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.
- Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- As a global company, our comprehensive benefits may vary based on location.
Company info
- At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
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