Reg Affairs Assoc. Director

**Mavericks Wanted** When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on 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. **What You'll Do #LI-RV1** The Associate Director/Director, Regulatory Advertising & Promotion is responsible for providing strategic regulatory leadership for promotional materials and external communications across assigned programs or brands. This role ensures that all promotional activities are compliant with FDA regulations, industry guidance, and company policy, while enabling the business to communicate effectively and competitively. In addition to timely review of materials, the Associate Director/Director is expected to help shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners to drive compliant, compelling communications that enable the business to deliver content and messaging effectively to its stakeholders. **Responsibilities** ### Strategic Regulatory Leadership - 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. ### Promotional Review & Governance - 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. ### Labeling & Claims Strategy - 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. ### Inspection & Enforcement Readiness - 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. **Where You'll Work** This role requires onsite presence at our San Francisco office. **Who You Are** ### Required - 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-functiona…