Executive Director, Regulatory Affairs

About Beeline Medicines 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. 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 programmes. The 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 maintain marketing approvals globally and develop and implement strategies for indication expansion in collaboration with cross‑functional programme teams. The incumbent will manage contractors/consultants globally, possibly lead direct reports in the future, represent the function on multidisciplinary 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 while taking clear ownership of assigned programmes. 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 for assigned project teams, forming strategies and serving as the US Regulatory Lead for 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 clinical trials and marketing application approval throughout the lifecycle. 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 and verifiable with urgency and accountability. Supervise, analyze, and disseminate intelligence on matters that may affect ongoing development programmes. Monitor, interpret and apply evolving regulations, guidance and regulatory intelligence to assigned programmes while collaborating with cross‑functional partners. Perform other duties and responsibilities as assigned. Qualifications Advanced degree (PhD, PharmD, or master’s level) in a relevant life science discipline. 15+ years of Regulatory Affairs experience in the pharmaceutical and/or biotechnology industry, with at least 5 years as a Global Regulatory Lead. Hands‑on experience with CTA submissions, NDA submissions, MAAs, briefing books and health authority responses. 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 at early and late‑stage development and with marketed products. Strategic oversight balanced with active execution and willingness to contribute directly. Entrepreneurial, self‑driven mindset with strong business acumen. Proactive identification and resolution of issues, using sound judgment to maintain momentum. Independent yet collaborative, able to take ownership without operating solitary. Ability to coach, mentor and develop direct reports and regulatory team members. Clear and concise communication with unambiguous direction to teams and stakeholders. Capability to translate complexity into clear priorities and actionable plans, enabling efficient multi‑stream execution. Strong interpersonal skills, including verbal and written communication. Salary Range The expected salary range for this position varies by location and will be communicated based on the country or region where the selected candidate is hired. Actual pay will be determined by experience, qualifications, location and other job‑related factors permitted by applicable local law. Salary Range: $281,000 – $344,000 USD 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, but are not limited to: 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. Equal Employment Opportunity 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, colour, 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. Privacy Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S. Information about Beeline Medicines privacy practices can be found at Privacy Policy – Beeline Medicines #J-18808-Ljbffr BioSpace