Boulevard Bio · 17 hours ago
Vice President of Regulatory Affairs
Boston, MA
Full-time
Hybrid
Director/Executive
12+ years expBoulevard Bio is a private, clinical-stage biotechnology company dedicated to developing best-in-class medicines for autoimmune diseases. They are seeking a Vice President of Regulatory Affairs to lead the global regulatory strategy and manage regulatory interactions for their clinical pipeline.
Biotechnology
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
Qualification
Required
Advanced degree in life sciences, pharmacy, or a related field
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
Preferred
PhD, PharmD, or MD preferred
MS/BS with substantial experience considered
Benefits
Company sponsored medical, dental, and vision coverage
Meaningful equity opportunities
Company
Boulevard Bio
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.
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase