Director, Regulatory CMC

<p><strong>Who We Are:</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 exciting place to catalyze and enable medical breakthroughs.</p> <p><strong>Position Description</strong>:</p> <p>The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical development and ensure seamless commercialization. Acting as a key partner to CMC and Quality, this role is responsible for the CMC content of all investigational and marketing applications, ensuring technical consistency and compliance across all stages of the product lifecycle, from early-stage development through commercialization. This role requires a blend of deep scientific fluency, meticulous attention to detail, and the ability to negotiate effectively with global health authorities. The ideal candidate has a deep understanding of the nuanced differences in regulatory pathways for both small molecules and monoclonal antibodies.</p> <p><strong>Key Responsibilities:</strong></p> <p><strong>Regulatory Strategy and Agency Interactions</strong></p> <ul> <li>Design and implement innovative global CMC regulatory strategies to secure approvals and maintain compliance for clinical and commercial products, identifying potential risks and creating robust mitigation plans</li> <li>Provide expert guidance on CMC requirements for both Small Molecules (NCEs) and Biologics (mAbs), including comparability protocols and stability requirements</li> <li>Act as the primary CMC point of contact for the FDA, EMA, and other global health authorities</li> <li>Lead preparations for and represent the company in formal regulatory meetings and in generating responses to Health Authority queries</li> <li>Assess the impact of manufacturing changes on global registrations and determine the necessary reporting categories globally</li> <li>Define the necessary data packages to support post-approval supplements</li> </ul> <p><strong>Submissions and Document Leadership</strong></p> <ul> <li>Author or direct the preparation, authoring, and technical review of CMC sections for global filings:</li> </ul> <p>-ND/IMPD: Investigational application