Senior Clinical Regulatory Lead -- Hybrid Role + PTO

Iterative Health; Glenview (IL); Hybride; USD 82 000 - 100 000; Plein temps

Avantages offerts par ce poste

Hybrid work environment

Medical, dental, vision coverage

401(k) with company match

Wellness and professional development

Résumé du poste

Iterative Health is seeking a Senior Clinical Regulatory Specialist to guide regulatory activities across Phase 2–4 trials. You will partner with sites, sponsors, CROs, and IRBs to ensure compliance, maintain inspection readiness, and drive continuous process improvements in a fast-paced network.

The role emphasizes independent management of multiple studies, strong GCP/FDA knowledge, and mentorship of team members within a hybrid work environment across NYC, Southlake, and Boston offices.

Qualifications

• 4+ years of clinical regulatory experience.
• Experience supporting Phase 2–4 sponsor trials.
• Strong knowledge of GCP and FDA regulations.
• Ability to manage multiple studies and sites independently.

Responsabilités

• Oversee regulatory activities across the study lifecycle.
• Provide regulatory guidance to sites and sponsors.
• Review regulatory documents and submissions for compliance.
• Monitor timelines and proactively address delays.
• Serve as regulatory SME to site teams and internal stakeholders.
• Ensure inspection readiness and remediation of findings.
• Mentor site teams on regulatory processes.
• Support training and SOP development.

Connaissances

Regulatory knowledge

GCP & FDA

Communication skills

Project management

Mentoring

Outils

CTMS

eSource

Regulatory software

Description du poste

Iterative Health is seeking a Senior Clinical Regulatory Specialist to guide regulatory activities across Phase 2–4 trials. You will partner with sites, sponsors, CROs, and IRBs to ensure compliance, maintain inspection readiness, and drive continuous process improvements in a fast-paced network.

The role emphasizes independent management of multiple studies, strong GCP/FDA knowledge, and mentorship of team members within a hybrid work environment across NYC, Southlake, and Boston offices.