Executive Director, Regulatory Affairs

About this role

<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 Executive Director, Regulatory Affairs will report to the Senior Vice President, Regulatory Affairs & Quality and serve as the Global Regulatory Lead to provide global regulatory strategy and leadership for assigned   programs. This role will be responsible for the development and execution of global regulatory strategy for the product, ensuring timely preparation, review and submission of IND/CTA/NDA/MAA and other Marketing Applications to regulatory authorities globally, and ensuring compliance with applicable regulatory requirements. In addition, this role will be responsible for maintaining any future marketing approvals globally and developing and implementing strategies for indication expansion in collaboration with cross functional program teams. The incumbent will manage contractors/consultants globally, possibly lead direct reports in the future, represent the function on multi-disciplinary teams, and must integrate company goals into the objectives and activities of the Regulatory Affairs Department.  This individual must be highly proactive, execution-oriented, collaborative, and able to maintain strong alignment with the Senior Vice President, Regulatory Affairs & Quality while taking clear ownership of assigned programs.</p> <p><span style="text-decoration: underline;"><strong><br>Work Arrangement & Location: </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: </strong></span></p> <ul> <li>As a seasoned professional in Regulatory Affairs, develop Global Regulatory strategies and serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams to form global strategies and serve as the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings</li> <li>Direct and coordinate the regulatory strategy and execution of assigned projects, including INDs, CTAs, NDAs, MAAs, briefing books, health authority responses, lifecycle management, and indication expansion.</li> <li>Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies; communicate clear, concise, project updates and recommendations to senior leadership</li> <li>Lead global regulatory submissions, lifecycle management and regulatory health authority interactions to support the conduct of clinical trials and approval of marketing applications throughout the lifecycle of assigned projects</li> <li>Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance</li> <li>Manage regulatory timelines, deliverables, documents, contractors/consultants, and future direct reports, ensuring work is accurate, complete, verifiable, and completed with urgency and accountability. Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements</li> <li>Supervise, analyze, and disseminate intelligence on matters that may affect ongoing development programs</li> <li>Monitor, interpret, and apply evolving regulations, guidance, and regulatory intelligence to assigned programs while collaborating closely with cross-functional partners to enable successful program outcomes. Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and collaborate with regulatory authorities; be primary liaison for day-to-day interactions</li> <li>Perform other duties and responsibilities as assigned.</li> </ul> <p><span style="text-decoration: underline;"><strong><br>Qualifications:</strong></span></p> <ul> <li>Education: Advanced degree (PhD, PharmD, or master's level) in a relevant life sciences discipline required.</li> <li>Minimum of 15+ years of Regulatory Affairs experience in pharmaceutical and/or biotechnology industry with at least 5 years as Global…