Reg Affairs Director
About The Position
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. 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. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
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.
Nice To Haves
- Experience in rare disease or specialty therapeutics.
- Strategic thinker: Balances compliance with business enablement.
- Sound judgment: Makes clear, defensible decisions under ambiguity.
- Influence without authority: Navigates cross-functional dynamics effectively.
- Risk calibration: Knows when to hold firm and when to flex.
- Clear communicator: Delivers direct, actionable guidance.
- You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies
Responsibilities
- 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.
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)
- 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
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
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What This Job Offers
Job Type
Full-time
Career Level
Senior
