Senior Clinical Regulatory Lead

Iterative Health; Cambridge (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work

Medical coverage

Mental health support

Health HSA/FSA

Unlimited PTO

401(k) match

Lunch benefit

Disability coverage

Wellness stipend

Job summary

Iterative Health in Cambridge, MA, is seeking a Senior Clinical Regulatory Specialist to oversee regulatory activities for Phase 2–4 trials across a national network. You will guide sites, sponsors, and CROs, ensuring regulatory compliance and inspection readiness.

Bring 4+ years in clinical regulatory or research operations, strong GCP/FDA knowledge, and experience with CTMS and regulatory submissions. Hybrid work model with on-site collaboration.

Qualifications

• 4+ years in clinical regulatory, and/or research operations supporting industry-sponsored trials.
• Experience with Phase 2–4 sponsor-initiated trials, site-facing regulatory work.
• Strong knowledge of GCP, FDA regs and IRB processes.
• Ability to manage regulatory activities across multiple studies/sites.
• Excellent organizational and communication skills.

Responsibilities

• Oversee regulatory activities across study lifecycle (start-up to closeout) for Phase 2–4 trials.
• Provide regulatory guidance to sites, sponsors, CROs, and internal teams.
• Review regulatory docs for quality and compliance; identify gaps and drive resolution.
• Monitor timelines, approvals, expirations, and CPAs; escalate risks as needed.

Skills

GCP & FDA regulatory

IRB processes

Regulatory submissions

CTMS experience

Regulatory oversight

Cross-functional collaboration

Tools

CTMS

Job description

Iterative Health in Cambridge, MA, is seeking a Senior Clinical Regulatory Specialist to oversee regulatory activities for Phase 2–4 trials across a national network. You will guide sites, sponsors, and CROs, ensuring regulatory compliance and inspection readiness.

Bring 4+ years in clinical regulatory or research operations, strong GCP/FDA knowledge, and experience with CTMS and regulatory submissions. Hybrid work model with on-site collaboration.