Reg Affairs Director

About this role

<div class="content-intro"><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Mavericks Wanted</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></span></p> <p><span data-contrast="auto">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</span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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. </span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">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.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p></div><h3><u>What You'll Do</u><span style="color: #ffffff;"><strong>-RV1</strong></span></h3> <p><span style="color: #000000;">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.</span></p> <p><span style="color: #000000;">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.</span></p> <p><span style="color: #000000;"><strong><u>Responsibilities</u></strong></span></p> <h3>Strategic Regulatory Leadership</h3> <ul> <li style="color: black !important;"><span style="color: #000000;">Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).</span></li> <li style="color: black !important;"><span style="color: #000000;">Provide proactive guidance on promotional strategy, claims development, and risk positioning.</span></li> <li style="color: black !important;"><span style="color: #000000;">Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.</span></li> <li style="color: black !important;"><span style="color: #000000;">Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.</span></li> <li style="color: black !important;"><span style="color: #000000;">Assess regulatory risk and recommend clear, practical mitigation strategies.</span></li> </ul> <h3>Promotional Review & Governance</h3> <ul> <li style="color: black !important;"><span style="color: #000000;">Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).</span></li> <li style="color: black !important;"><span style="color: #000000;">Ensure materials are accurate, balanced, and supported by substantial evidence.</span></li> <li style="color: black !important;"><span style="color: #000000;">Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns.</span></li> <li style="color: black !important;"><span style="color: #000000;">Support advisory boards, speaker programs, and field training materials as needed.</span></li> <li style="color: black !important;"><span style="color: #000000;">Contribute to development and refinement of internal SOPs and review processes.</span></li> </ul> <h3>Labeling & Claims Strategy</h3> <ul> <li style="color: black !important;"><span style="color: #000000;">Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.</span></li> <li…