Senior Clinical Regulatory Lead for Trials

Iterative Health; New York (NY); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Hybrid work

Excellent medical/dental coverage

Wellness stipend

401(k) with company match

Paid time off

Job summary

Iterative Health is hiring a Senior Clinical Regulatory Specialist to support Phase 2–4 industry-sponsored trials across our network. You will guide regulatory activities from startup to closeout, partnering with sites, sponsors, CROs, IRBs, and internal teams to ensure compliant, timely submissions.

The role requires strong GCP knowledge, experience with CTMS and regulatory documentation, and the ability to manage multiple studies and stakeholders in a fast-paced environment.

Qualifications

• 4+ years in clinical research or regulatory operations for industry trials.
• Strong knowledge of GCP, FDA regulations, IRB processes, and SOPs.
• Experience handling regulatory submissions and site-facing activities.

Responsibilities

• Oversee lifecycle regulatory activities across Phase 2–4 trials.
• Guide sites and internal teams on regulatory requirements and timelines.
• Review documentation for completeness and inspection readiness.
• Mentor site teams on regulatory processes and templates.
• Monitor timelines, risks, and CAPAs with cross-functional partners.

Skills

Regulatory Operations

IRB Knowledge

GCP Knowledge

CTMS experience

Regulatory Submissions

Cross-functional

Documentation skills

Job description

Iterative Health is hiring a Senior Clinical Regulatory Specialist to support Phase 2–4 industry-sponsored trials across our network. You will guide regulatory activities from startup to closeout, partnering with sites, sponsors, CROs, IRBs, and internal teams to ensure compliant, timely submissions.

The role requires strong GCP knowledge, experience with CTMS and regulatory documentation, and the ability to manage multiple studies and stakeholders in a fast-paced environment.