Senior Director, Regulatory Affairs CMC – Biologics

<div class="content-intro"><p><span style="text-decoration: underline;"><strong>About Beeline Medicines:</strong></span></p> <p>Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.</p></div><p><span style="text-decoration: underline;"><strong>Job Summary:</strong></span></p> <p>The Senior Director, Regulatory Affairs CMC – Biologics provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's biologics assets within the immunology and inflammation (I&amp;I) portfolio, including monoclonal antibodies and other large molecule therapeutic modalities. This role is responsible for developing and executing biologics CMC regulatory strategies from early clinical development through BLA filing and post-approval lifecycle management, serving as the company's foremost authority on biologics CMC regulatory science. The Senior Director collaborates closely with Process Development, Analytical Sciences, Quality, and external biologics CMOs to ensure that programs are developed, characterized, and submitted in alignment with FDA, EMA, and global Health Authority expectations for biological products. As a senior leader within the Regulatory Affairs organization, this individual also contributes to cross-functional regulatory strategy and plays a foundational role in shaping the company's biologics CMC regulatory infrastructure.</p> <p><span style="text-decoration: underline;"><strong><br>Work Arrangement &amp; Location:&nbsp;</strong></span></p> <p><strong>Hybrid - </strong>This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as <strong>Tuesday and Wednesday</strong>. Additional on-site days may be required based on business needs, team priorities, or leadership direction.</p> <p><span style="text-decoration: underline;"><strong><br>Essential Duties and Responsibilities: <