Regulatory Affairs Specialist

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide. As a Clinical Regulatory Specialist at Iterative Health, you will play an important role in supporting the compliant and efficient execution of Phase 2–4 industry-sponsored clinical trials across our clinical research network. Working under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle—from study start-up and activation through ongoing maintenance and closeout. You will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements. This role is ideal for someone with clinical research experience who is highly organized, detail-oriented, and comfortable managing multiple studies and priorities in a fast-paced, collaborative environment. Where You’ll Drive Impact Facilitate regulatory activities across the study lifecycle, including study start-up, activation, maintenance, and closeout for Phase 2–4 industry-sponsored clinical trials. Prepare, collect, review, and maintain essential regulatory documents to support study activation and ongoing compliance. Prepare and coordinate initial IRB submissions, amendments, continuing reviews, safety reports, and other required submissions on behalf of clinical research sites. Track regulatory submissions, approvals, expirations, and outstanding documentation to ensure requirements and study timelines are met. Maintain Investigator Site Files (ISFs) and other regulatory documentation, ensuring records are accurate, complete, current, and inspection-ready. Partner With Sites & Study Stakeholders Serve as a regulatory partner to assigned clinical research sites, helping site teams navigate study-specific regulatory requirements and timelines. Serve as a primary point of contact for clinical site staff on regulatory activities, as assigned. Collaborate with sponsors, CROs, monitors, IRBs, and internal stakeholders to address regulatory requests, resolve documentation gaps, and support study milestones. Maintain clear, timely, and well-documented study correspondence with internal and external stakeholders. Support Compliance & Inspection Readiness Support site compliance with study protocols, Good Clinical Practice (GCP), applicable FDA regulations and guidance, IRB requirements, and Iterative Health Standard Operating Procedures (SOPs). Participate in monitoring visits, audits, and other quality or compliance activities, including preparation and follow-up of regulatory documentation. Proactively identify missing, incomplete, or expiring documentation and partner with appropriate stakeholders to drive timely resolution. Identify and escape regulatory risks, delays, or compliance concerns and support resolution and corrective actions as appropriate. Performs related duties as requested What You Bring to the Team 2+ years of relevant experience in clinical research, regulatory affairs, clinical operations, or a related field supporting industry-sponsored clinical trials. Experience supporting Phase 2–4 sponsor-initiated clinical trials, ideally in a site-facing regulatory capacity. Previous experience as a Clinical Research Coordinator (CRC), Regulatory Coordinator/Specialist, or in another site-facing clinical research role with responsibility for regulatory activities. Working knowledge of Good Clinical Practice (GCP), applicable FDA requirements, IRB processes, and clinical research Standard Operating Procedures (SOPs). Experience preparing and maintaining essential regulatory documents and supporting IRB submissions throughout the study lifecycle. Strong organizational, time-management, and prioritization skills, with the ability to manage multiple studies, sites, deadlines, and competing priorities. Exceptional attention to detail and a commitment to maintaining accurate, complete, and inspection-ready documentation. Strong written and verbal communication skills with the ability to collaborate effectively with clinical site staff, internal teams, sponsors, CROs, and other external stakeholders. Sound judgment, problem-solving skills, and the ability to identify issues and elevate appropriately. Experience with a Clinical Trial Management System (CTMS), electronic regulatory platform, eSource, or other clinical research technology preferred. How We Work Collaborative and low-ego team environment High ownership and accountability culture Fast-paced and highly iterative growth environment Open communication and continuous learning mindset Mission-driven organization focused on improving patient outcomes Comfortable navigating evolving business priorities and opportunities Benefits That Support You We believe great teams do their best work when they feel supported — professionally and personally. Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health Mental health and wellness support through Spring Health Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years 401(k) program with a company match of up to 3% (up to $3,000 annually) Weekly in-office lunch benefit every Tuesday 100% company-paid short-term and long-term disability coverage Annual wellness and professional development stipend to support your health and growth And more! At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact View email address on click.appcast.io. #J-18808-Ljbffr