Regulatory Specialist

A company is looking for a Regulatory Specialist.

Key Responsibilities

Update Clinical Trials Management System (CTMS) with essential profile information and regulatory documentation

Prepare regulatory documentation packets and assist with regulatory actions during site selection

Provide regulatory guidance and maintain study-specific regulatory files in compliance with FDA guidelines

Required Qualifications

Bachelor's degree in a relevant field

Experience in regulatory affairs or clinical research

Knowledge of FDA regulations and IRB processes

Ability to work effectively with cross-functional teams

Familiarity with Clinical Trials Management Systems (CTMS)