Executive Director, Regulatory Affairs

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 fully. Job Summary 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. Work Arrangement & Location Hybrid – This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week — currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction. Essential Duties and Responsibilities 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. 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. Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies; communicate clear, concise, project updates and recommendations to senior leadership. 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. Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance. Manage regulatory timelines, deliverables, documents, contractors/consultants, and future direct reports, ensuring work is accurate, complete, verifiable, and completed with urgency and accountability. Supervise, analyze, and disseminate intelligence on matters that may affect ongoing development programs. 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. Perform other duties and responsibilities as assigned. Qualifications Advanced degree (PhD, PharmD, or master’s level) in a relevant life sciences discipline required. Minimum of 15+ years of Regulatory Affairs experience in pharmaceutical and/or biotechnology industry with at least 5 years as Global Regulatory Lead. Hands‑on experience with CTA submissions, NDA submissions, MAAs, briefing books, and health authority responses required. Immunology experience highly preferred. Experience in effective negotiations with FDA and EMA and other global health authorities. Demonstrated track record of leading marketing applications globally, from submission to approval and indication post‑marketing maintenance. Experience with investigational drugs, including early and late‑stage development, and marketed products. Balances strategic oversight with active involvement in execution and willingness to roll up sleeves and contribute directly. Demonstrates an entrepreneurial, self‑driven mindset, proactively solving problems and anticipating needs, while exercising strong business acumen. Proactively identifies issues and drives resolution, using sound judgment to remove obstacles and maintain momentum. Independent but collaborative; able to take ownership without operating as a lone ranger. Demonstrated ability to coach, mentor, and develop direct reports as well as other members of the Regulatory team. Communicates clearly and concisely, providing unambiguous direction to teams and stakeholders. Translates complexity into clear priorities and actionable plans, enabling efficient execution across multiple workstreams. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Salary Range The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by applicable local law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance. Benefits Competitive health and wellness coverage (structure and premiums vary by country). Paid time off, public holidays, and additional leave entitlements in accordance with local requirements. Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process. Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. Reasonable Accommodation If you require a reasonable accommodation to participate in the application or interview process, please contact View email address on click.appcast.io to request an accommodation. We are committed to providing equal access to all candidates. #J-18808-Ljbffr