Regulatory Manager

A company is looking for a Regulatory Manager.

Key Responsibilities

Manage regulatory submissions, documentation, education, training, and compliance

Coordinate research activities with clinical research staff, sponsors, and IRBs

Prepare and maintain regulatory documentation and ensure compliance with FDA and ICH-GCP guidelines

Required Qualifications

Bachelor's Degree in healthcare or a science-related field

Minimum of 2 years of experience in a regulatory role within clinical research

Strong proficiency in Microsoft Office and web applications

ICH-GCP Certification

Knowledge of human research policies and regulations preferred