Senior Clinical Regulatory Specialist

The posting, as Iterative Health wrote it

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 Senior Clinical Regulatory Specialist at Iterative Health, you will play a key role in supporting the compliant execution of Phase 2–4 industry-sponsored clinical trials across our clinical research network. You will provide regulatory guidance and oversight throughout the study lifecycle, from start-up and site activation through maintenance and closeout.

You will partner with clinical research sites, internal teams, sponsors, CROs, IRBs, and other stakeholders to ensure regulatory requirements are completed accurately and efficiently. You will also help identify regulatory risks, resolve complex issues, and improve processes across the network.

This role is ideal for an experienced clinical research professional with strong regulatory expertise who can independently manage multiple studies, priorities, and stakeholders in a fast-paced environment.

Where You’ll Drive Impact

Regulatory Operations & Compliance

• Facilitate and oversee regulatory activities across the study lifecycle, including study start-up, site activation, maintenance, and closeout for Phase 2–4 industry-sponsored clinical trials.
• Provide regulatory guidance and oversight to research sites across multiple studies, ensuring timely and accurate completion of regulatory requirements.
• Review and QC regulatory documentation and submissions for completeness, accuracy, consistency, and compliance, identifying gaps and driving resolution.
• Manage complex regulatory activities and submissions, including IRB applications, amendments, continuing reviews, safety reports, unexpected events, and other study-specific regulatory requirements.
• Monitor regulatory timelines, approvals, expirations, and outstanding requirements to proactively identify potential delays or compliance risks.
• Identify, assess, and escalate regulatory risks and compliance issues, partnering with sites, sponsors, CROs, and internal stakeholders to develop and implement appropriate corrective and preventive actions.
• Serve as a subject matter resource for site teams and internal stakeholders on regulatory requirements, study-specific expectations, and best practices.
• Ensure regulatory documentation and processes remain consistent, compliant, and inspection-ready across the resea

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regulatory activities.

• Experience mentoring, training, or providing guidance to less experienced team members preferred.
• 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, Southlake, TX 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!

New York pay range
$82,000 — $100,000 USD

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 CandidateAccommodations@iterative.health.