Clinical Trials Regulatory Specialist

Tandem Intermediate LLC; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

Tandem Intermediate LLC is seeking a Regulatory Specialist to coordinate regulatory documentation and ensure compliance across study start-up, submissions, and lifecycle documentation for clinical trials.

You will work with the Regulatory Manager, clinical teams, and sponsors to keep ISFs, regulatory binders, and electronic systems current, audit-ready, and aligned with ICH-GCP and FDA requirements.

Qualifications

• Familiarity with FDA and ICH-GCP guidelines.
• Ability to manage multiple regulatory timelines.
• Experience with IRB submissions preferred.

Responsibilities

• Prepare and submit regulatory documents to IRBs and sponsors.
• Maintain ISFs and regulatory binders.
• Coordinate start-up documents (site questionnaires, CVs, delegation logs).
• Monitor compliance with ICH-GCP and FDA regulations.
• Serve as liaison between staff, investigators, sponsors, and IRBs.
• Keep files audit-ready and support audits.

Skills

FDA regulations

ICH-GCP

IRB processes

Organizational skills

Written & verbal communication

Regulatory platforms

MS Office

Education

Bachelor's degree

Tools

CRIO

Complion

Veeva

Job description

Tandem Intermediate LLC is seeking a Regulatory Specialist to coordinate regulatory documentation and ensure compliance across study start-up, submissions, and lifecycle documentation for clinical trials.

You will work with the Regulatory Manager, clinical teams, and sponsors to keep ISFs, regulatory binders, and electronic systems current, audit-ready, and aligned with ICH-GCP and FDA requirements.