Senior Clinical Regulatory Lead - Hybrid (Phase 2–4)

Iterative Health; Memphis (TN); Hybrid; USD 82,000 - 100,000; Full time

Benefits offered by this job

Hybrid work environment

Comprehensive medical, dental, vision

Wellness stipend

401(k) program with matching

Paid time off

Job summary

Iterative Health, a healthcare technology and services company, is seeking a Senior Clinical Regulatory Specialist to support compliant execution of Phase 2–4 industry-sponsored trials across our network. You will provide regulatory guidance from startup to closeout, partnering with sites, sponsors, CROs, IRBs, and internal teams to ensure timely and accurate regulatory deliverables.

This role requires strong regulatory expertise, the ability to manage multiple studies and stakeholders in a

Qualifications

• 4+ years of clinical regulatory experience in industry-sponsored trials.
• Strong knowledge of GCP, FDA regulations and IRB processes.
• Experience reviewing regulatory documents for quality and compliance.
• Experience with regulatory submissions and site-level regulatory tasks.
• Familiarity with CTMS or electronic regulatory platforms.

Responsibilities

• Oversee regulatory activities across the study lifecycle for Phase 2–4 trials.
• Provide guidance to sites and internal teams on regulatory requirements.
• Review regulatory docs for completeness and compliance; identify gaps.
• Manage IRB submissions, amendments, continuing reviews, and safety reports.
• Monitor timelines, approvals, expirations, and potential delays; mitigate risks.
• Serve as a regulatory SME to sites, sponsors, CROs, and internal stakeholders.
• Maintain inspection-ready regulatory records and documentation.

Skills

Regulatory expertise

GCP & FDA regulations

IRB processes

Regulatory submissions

CTMS experience

Tools

CTMS

eRegulatory system

Job description

Iterative Health, a healthcare technology and services company, is seeking a Senior Clinical Regulatory Specialist to support compliant execution of Phase 2–4 industry-sponsored trials across our network. You will provide regulatory guidance from startup to closeout, partnering with sites, sponsors, CROs, IRBs, and internal teams to ensure timely and accurate regulatory deliverables.

This role requires strong regulatory expertise, the ability to manage multiple studies and stakeholders in a