Regulatory Affairs Director

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $230k - $285k / year

⏰ Full Time

🔴 Lead

👔 Director

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BridgeBio

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

BridgeBio is a biotechnology company focused on designing transformative medicines for patients with genetic diseases. It employs a novel approach to drug development by integrating finance with science to deliver solutions as efficiently as possible. The company is committed to developing not only life-changing drugs but also leaders in the field, encouraging hands-on engagement and the pursuit of innovation. BridgeBio actively seeks investment to help achieve its mission of providing solutions for unique patient populations with unmet needs. Headquartered in Palo Alto, CA, BridgeBio emphasizes bridging the gap between scientific advancements and patient care.

📋 Description

• 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.

🎯 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