Sr. Director, Regulatory Affairs - CMC

<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></h3> <p>Lead CMC regulatory strategy and execution across development and post-approval programs, ensuring high-quality submissions aligned with global regulatory requirements. Serve as a strategic Regulatory CMC subject-matter expert and key cross-functional partner, influencing regulatory decision-making and program execution. This role is primarily an individual contributor position with the opportunity to mentor, coach, and potentially manage team members as organizational needs evolve. The ideal candidate brings deep Regulatory CMC expertise, strong cross-functional leadership skills, demonstrated experience with global and ROW filings (e.g., MENA, LATAM, APAC), and practical fluency leveraging AI-enabled and digital tools to improve regulatory workflows and deliverables.</p> <p> </p> <h3>