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, the Company is developing medicines that have the opportunity to provide durable, life-changing impact.

About the role

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 is responsible for the development and execution of global regulatory strategy, ensuring timely preparation, review, and submission of IND/CTA/NDA/MAA and other Marketing Applications to regulatory authorities globally, while ensuring compliance with applicable regulatory requirements. The incumbent will maintain future marketing approvals globally, develop strategies for indication expansion, manage contractors/consultants, and represent the function on multi-disciplinary teams.

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.
• Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and collaborate with regulatory authorities; be primary liaison for day-to-day interactions.
• 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 (GRL).
• 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 (e.g., FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings, and/or EU oral explanations/scientific advice, etc.).
• Demonstrated track record of leading marketing applications globally, from submission to approval and indication postmarketing 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 their sleeves and contribute directly.
• Demonstrates an entrepreneurial, self-driven mindset, proactively solving problems and anticipating needs, while exercising strong business acumen to keep leadership appropriately informed and engaged.
• 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.

Schedule

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.

Pay

The expected salary range for this position is $281,000 - $344,000 USD. 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

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include:

• 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.
• Flexible work arrangements / hybrid schedule.

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.