Senior Clinical Regulatory Specialist

The role

You will support the compliant execution of Phase 2–4 industry-sponsored clinical trials across a clinical research network. You will provide regulatory guidance and oversight throughout the study lifecycle, from start-up to closeout.

What you will do

• Facilitate and oversee regulatory activities across the study lifecycle
• Provide regulatory guidance and oversight to research sites
• Review and QC regulatory documentation and submissions
• Manage complex regulatory activities and submissions including IRB applications
• Monitor regulatory timelines, approvals, and expirations
• Identify, assess, and escalate regulatory risks and compliance issues
• Serve as a subject matter resource for site teams and internal stakeholders
• Maintain accurate regulatory records, trackers, and documentation
• Serve as a senior regulatory point of contact for assigned research sites
• Drive continuous improvement of regulatory processes, tools, and workflows

Required qualifications

• 4+ years of relevant experience in clinical research, clinical regulatory, and/or research operations supporting industry-sponsored clinical trials
• Strong experience supporting Phase 2–4 sponsor-initiated clinical trials
• Previous experience as a Clinical Research Coordinator (CRC), Regulatory Coordinator/Specialist, or in another clinical research role with significant responsibility for regulatory activities
• Strong working knowledge of Good Clinical Practice (GCP), applicable FDA regulations and guidance, IRB processes, and clinical research SOPs
• Demonstrated experience independently managing regulatory activities across multiple studies and/or research sites
• Experience reviewing regulatory documentation and submissions for quality, completeness, and compliance
• Strong organizational, time-management, and prioritization skills
• Exceptional attention to detail
• Strong written and verbal communication skills
• Demonstrated ability to work independently, exercise sound judgment, and take ownership of complex regulatory activities

Nice to have

• Experience mentoring, training, or providing guidance to less experienced team members
• Experience with a Clinical Trial Management System (CTMS), electronic regulatory platform, eSource, or other clinical research technology

Benefits

• 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
• Commuter FSA contributions supported by Iterative Health
• Unlimited PTO
• 12 company holidays
• 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

About the company

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The company has a network of 100+ sites across the US, Europe, India, and Australia.