Vice President of Regulatory Affairs

Boulevard Bio is a private, clinical‑stage biotechnology company dedicated to developing best‑in‑class medicines to address B cell driven autoimmune diseases of significant clinical and commercial unmet need to transform patient’s lives. Our pipeline is anchored by a highly differentiated and potentially best‑in‑class BAFF/APRIL dual inhibitor. This lead candidate offers an accelerated clinical path toward establishing a new disease‑modifying standard of care in IgA Nephropathy (IgAN). Beyond our lead asset, our pipeline includes two additional programs focused on B cell reset and combination of B cell biology and other drivers of disease. Founded and backed by Deerfield Management, Boulevard Bio is led by a team of industry veterans with a proven track record of advancing molecules from preclinical discovery through clinical development and successful commercialization as well as fund‑raising. With a strong foundation and a clear strategic vision, Boulevard aims to create significant value creation and clinical impact in the near term. We are seeking an experienced and visionary Vice President of Regulatory to lead the strategic development and supply of biopharmaceutical products from discovery through clinical proof of concept. This role is ideal for a dynamic leader who thrives in a fast‑paced, entrepreneurial environment and can effectively bridge strategic planning with day‑to‑day operational excellence. Key Responsibilities: Develop and own global regulatory strategy for the company’s pipeline, with an initial focus on IND maintenance and early‑phase clinical development Serve as the primary point of contact with regulatory authorities (e.g., FDA; ex‑US agencies as needed), leading meeting requests, briefing packages, and formal interactions Oversee preparation, submission, and lifecycle management of regulatory filings, including IND amendments, safety reports, annual reports, and ex‑US clinical trial applications as the company expands Partner closely with Clinical, Nonclinical, CMC, and Quality to ensure development plans, protocols, reports, and manufacturing changes are aligned with regulatory requirements and strategy Provide hands‑on authorship, review, and quality control of key regulatory documents (e.g., IND components, IB, regulatory briefing materials, responses to agency questions) Anticipate regulatory risks, propose mitigation strategies, and advise executive leadership on regulatory pathways, designations, and opportunities to accelerate development Establish scalable regulatory processes, systems, and standards appropriate for a lean startup environment, including document management and submission planning Select, manage, and mentor internal regulatory staff over time; effectively oversee external consultants, vendors, and publishing partners Monitor evolving global regulatory guidelines and expectations, and translate changes into practical guidance for internal teams Qualifications: Advanced degree in life sciences, pharmacy, or a related field (PhD, PharmD, or MD preferred; MS/BS with substantial experience considered) 12+ years of regulatory affairs experience in the biopharma/biotech industry, including significant hands‑on responsibility for early development programs and INDs Demonstrated experience leading regulatory strategy and health authority interactions for clinical‑stage assets; prior responsibility for at least one IND (initial filing and/or major amendments) Strong cross‑functional understanding of clinical development, nonclinical, and CMC, with the ability to integrate input into cohesive regulatory strategies Proven ability to operate effectively in a small, fast‑paced, resource‑constrained startup, functioning both as a strategic leader and individual contributor Excellent written and verbal communication skills, including clear regulatory document writing and confident representation of the company with health authorities and senior leadership Why Boulevard Bio: Culture, Impact, and Accelerated Growth: As an early clinical‑stage company, your contributions will be vital and impactful. You will have the opportunity to work closely with industry veterans, contribute to a range of projects across various stages of the clinical development lifecycle, and build a breadth of experience while working in an organization that values people. Stability and Vision: Backed by Deerfield Management, we combine the agility of a startup with the strategic resources of a longstanding healthcare investment firm. Total Rewards: We believe in sharing our success with the people who build it. We offer a competitive compensation package, comprehensive benefits including company sponsored medical, dental, and vision coverage, and meaningful equity opportunities that allow you to have a stake in the value you create. #J-18808-Ljbffr