Regulatory Affairs Specialist Consultant

ClinChoice

🌍 100% Remote Full-time

Job Description

Overview

ClinChoice is searching for a Sr. Regulatory Affairs Specialist Consultant for a 12‑month contract with the possibility of extension to join one of our clients. The role offers the advantage of working directly for a single sponsor while providing the security and career opportunities of a global CRO. ClinChoice is a global full‑service CRO dedicated to quality, professional development, and a supportive culture.

Key Responsibilities

  • Support collection and tracking of regulatory documentation for INVIMA submissions.
  • Perform initial completeness checks of regulatory documentation.
  • Maintain organized and audit‑ready regulatory files.
  • Assist with execution of approved regulatory plans under supervision.
  • Update regulatory systems, databases, and trackers.
  • Support coordination of regulatory projects and cross‑functional requests.
  • Ensure compliance with company policies and pr...