Clinical Research Regulatory Lead

allied executive solutions; New York (NY); Hybrid; USD 70,000 - 98,000; Full time

Job summary

Allied Executive Solutions is seeking a Regulatory Specialist to manage regulatory documentation for clinical research and human subjects protection. The role supports start-up activities, IRB submissions, and ongoing compliance, ensuring accurate, inspection-ready files and timely updates across protocols, amendments, and training.

The position emphasizes regulatory accuracy, strong documentation controls, and clear communication with sponsors, IRBs, and study teams in a collaborative,

Qualifications

• Bachelor's degree in health sciences, public health, healthcare administration, regulatory affairs, life sciences, or related field preferred.
• Experience in clinical research, regulatory affairs, compliance, IRB coordination, or healthcare administration.
• Strong organizational and document management skills.
• High attention to detail and ability to manage multiple deadlines.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office, Adobe, shared drives, electronic regulatory systems, and document tracking tools.

Responsibilities

• Regulatory Study Start-Up: Review study materials and prepare regulatory documents for study activation.
• IRB Submissions and Maintenance: Prepare, submit, track and maintain IRB applications and amendments.
• Regulatory Documentation and Essential Files: Maintain complete, inspection-ready regulatory files and ensure version control.
• Compliance Monitoring and Audit Readiness: Support internal quality checks and respond to monitor findings and corrective actions.
• Training and Staff Documentation: Track staff training and ensure delegation of authority logs and training compliance.
• Policy, Process, and Communication Support: Develop SOPs, trackers, and workflows; communicate regulatory requirements clearly.

Skills

Regulatory knowledge

Documentation management

Communication skills

Attention to detail

Education

Bachelor's degree in health sciences/related field

Tools

Microsoft Office

Adobe

Electronic regulatory systems

Job description

Allied Executive Solutions is seeking a Regulatory Specialist to manage regulatory documentation for clinical research and human subjects protection. The role supports start-up activities, IRB submissions, and ongoing compliance, ensuring accurate, inspection-ready files and timely updates across protocols, amendments, and training.

The position emphasizes regulatory accuracy, strong documentation controls, and clear communication with sponsors, IRBs, and study teams in a collaborative,