<div class="content-intro">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. </div><h3>EIDOS THERAPEUTICS, INC.</h3> POSITION DESCRIPTION Job Title: Associate Director/Director, Regulatory Affairs CMC Reports to: Executive Director, Regulatory Affairs CMC This regulatory professional will have demonstrated the ability to work independently under the direction of his/her manager. This individual will manage internal regulatory processes, prepare documents for regulatory submissions in compliance with global health authority regulations. In conjunction with regulatory affairs leadership, he/she will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries. Furthermore, the successful candidate will have demonstrated knowledge of regulatory requirements and guidelines and be able to apply their knowledge to daily work, and as needed represent regulatory affairs CMC as part of an interdisciplinary team. REMOTE – This is a U.S.-based role that will require quarterly, or as needed visits to our San Francisco Office. Responsibilities include but are not limited to the following: <ul> <li> Develop global CMC regulatory strategies in collaboration with manager and CMC subject-matter experts to meet business objectives for the Eidos program </li> <li> Collaborate with cross-functional teams (e.g. Regulatory Int.) to create and prepare CMC sections of regulatory dossiers marketing applications (ROW) <ul> <li> Help prepare and communicate timelines </li> <li> Plan and coordinate preparation of the CMC sections </li> <li> Manage the author, review and approval workflows </li> <li> Provide recommendations to team on regulatory strategy as needed </li> </ul> </li> <li> Provide RA CMC support for Health Authority interactions, including coordination of drafting and reviewing meeting requests and briefing books.</p&

AD/Director, Regulatory Affairs CMC

Job Description