Overview
Remote – United States. Join BridgeBio as Associate Director / Director, Regulatory Advertising and Promotion.
What You’ll Do
Provide strategic regulatory leadership for promotional materials and external communications across assigned programs or brands.
Responsibilities
- Serve as the ad promo regulatory lead for assigned products.
- 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.
- Support development of core claims documents and messaging frameworks.
- Monitor FDA enforcement actions and emerging trends; support responses to OPDP inquiries.
- Contribute to inspection readiness related to promotional review processes.
Qualifications
- Advanced scientific degree (PharmD, PhD, MD) or equivalent.
- 8+ years of pharmaceutical experience with 5+ years 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.
- Preferred: Experience in rare disease or specialty therapeutics.
- Strategic thinker balancing compliance with business enablement.
- Influence without authority and risk calibration skills.
- Curiosity and adaptability in adopting AI‑powered tools and technologies.
Benefits
- Market‑leading compensation.
- 401(k) with employer match.
- Employee Stock Purchase Program (ESPP).
- Pre‑tax commuter benefits.
- Referral bonus for hired candidates.
- Subsidized lunch and parking on in‑office days.
- 100% employer‑paid medical, dental, and vision premiums for you and dependents.
- HealthSavings Account (HSA) with annual employer contributions.
- Flexible Spending Accounts (FSA).
- Expanded mental health support (therapy and coaching).
- Hybrid work model with flexibility.
- Flexible, paid time off and company‑paid holidays.
- Comprehensive parental leave.
BridgeBio is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other protected class.
California salary range $245,000–$285,000 USD. Final compensation will depend on experience and location.
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