Executive Director, Regulatory CMC

<h3><u>Mavericks Wanted<br></u></h3> <p>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<br> <br>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. <br> <br>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.</p> <h3><u>What You'll Do</u></h3> <p>The Executive Director, Regulatory CMC provides strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products. This role partners closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.</p> <h3><u>Responsibilities</u></h3> <p><strong>CMC Regulatory Strategy & Leadership</strong></p> <ul> <li>Define and execute global CMC regulatory strategies for investigational and marketing applications (e.g., IND/CTA/IMPD/MAA/NDA) and lifecycle changes</li> <li>Serve as the primary CMC regulatory lead for one or more programs and/or as functional head for Regulatory CMC</li> <li>Provide leadership, coaching, and development for Regulatory CMC staff and contractors; build scalable processes as the portfolio grows</li> </ul> <p><strong>Submissions & Health Authority Interactions</strong></p> <ul> <li>Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests)</li> <li>Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.)</li> <li>Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks</li> </ul> <h3><u>Where You'll Work</u></h3> <p>This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.</p> <h3><u>Who You Are</u></h3> <ul> <li>Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered)</li> <li>Typically <strong>12–15+ years</strong> of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products—tailor as needed)</li> <li>Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred)</li> <li>Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks)</li> <li>Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment</li> <li>Excellent writing, communication, and executive presentation skills</li> <li>You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies</li> </ul> <p><strong><u>Rewarding Those Who Make the Mission Possible</u></strong></p> <p>We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. </p> <p><strong>Financial Benefits:</strong></p> <ul> <li>Market leading compensation </li> <li>401K with 100% employer match on first 3% & 50% on the next 2%</li> <li>Employee stock purchase program</li> <li>Pre-tax commuter benefits</li> <li>Referral program with $2,500 award for hired referrals</li> </ul> <p><strong>Health & Wellbeing:</strong></p> <ul> <li>Comprehensive health care with 100% premiums covered - no cost to you and dependents</li> <li>Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)</li> <li>Hybrid work model - employees have the autonomy in where and how they do their work </li> <li>Unlimited flexible paid time off - take the time that you need</li> <li>Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents</li> <li>Flex spending accounts & company-provided group term life & disability </li> <li>Subsidized lunch via Forkable on days worked from our office</li> </ul> <p><strong>Skill Development & Career Paths:</strong></p> <ul> <li>People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility</li> <li>We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching</li> <li>We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities\</li> </ul> <p><span style="color: rgb(246, 235, 219);" data-olk-copy-source="MessageBody">#LI-SG1</span></p> <p> </p> <p> </p><div class="content-pay-transparency"><div class="pay-input"><div class="description"><div> <div>At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.</div> </div></div><div class="title">Salary</div><div class="pay-range"><span>$305,000</span><span class="divider">—</span><span>$350,000 USD</span></div></div></div>