Director, Regulatory Affairs

<p><strong>Who We Are:&nbsp;</strong></p> <p>Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science, and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and&nbsp; exciting place to catalyze and enable medical breakthroughs.&nbsp;</p> <p><strong>Position Description</strong>:&nbsp;</p> <p>Calico is seeking a Regulatory Director that will be responsible for, in collaboration with development partners as applicable, developing and implementing innovative regulatory strategies to support development programs, in compliance with health authority guidelines and regulations. The successful candidate should be able to collaborate effectively with cross-functional representatives, collaboration partners, external vendors, and stakeholders, while maintaining a positive team environment.&nbsp;&nbsp;</p> <p><strong>Position Responsibilities:&nbsp;</strong></p> <ul> <li>Accountable to develop and execute the world-wide regulatory strategy for assigned programs (from IND-enabling to clinical proof-of-concept and beyond), which may include programs that are first-in-class, where no or limited FDA guidance exists, that have an external business partner, and where there are multiple indications</li> <li>Provide high-level regulatory counsel to Executive Leadership, Clinical Development, CMC, and Commercial teams regarding clinical trial designs, surrogate endpoints, accelerated approval strategies, and risk mitigation</li> <li>Lead interactions with global health agencies to inform global regulatory/ registration requirements for assigned programs, developing briefing packages for such engagements</li> <li>Collaborate with the executive team to define regulatory strategies consistent with Calico’s mission for both internal and partnership programs&nbsp;</li> <li>Oversee or directly enable the compilation, review, and submission of regulatory applications and submissions to agencies, ensuring accuracy, completeness, and timeliness&nbsp;</li> <li>Collaborate with CMC, CMC Regulatory, and other stakeholders to develop effective CMC regulatory strategies&nbsp;</li> <li>Represent Regulatory Affairs on development teams and support development teams in interpreting and applying regulations and guidance documents</li> <li>Offer strategic and regulatory compliance input to protocols, reports, and other source do