Regulatory Affairs Coordinator

Job Description:

• Manage and plan regulatory affairs compliance for industry sponsors and/or sites in networks
• Work with regulatory affairs management, department director, and/or primary investigators to ensure compliance
• Prepare for auditing activities while meeting strict deadlines
• Process regulatory document signature requests through an electronic signature platform
• Track documents pending site regulatory signatures
• Provide site-level regulatory support to Clinical Operations sites and internal department managers
• Establish and maintain document management systems for regulatory paper and electronic files
• Maintain FDA and GCP-required regulatory documentation for individual sites, studies, sponsors, and/or networks
• Ensure regulatory documentation complies with local SOPs for format and content
• Maintain updated physician credentials and other critical documentation
• Triage site requests for regulatory support and identify the correct pathway for issue resolution

Requirements:

• Associate Degree required; Bachelor’s Degree preferred
• Regulatory experience preferred
• Customer service experience preferred
• Knowledge of FDA and Good Clinical Practice (GCP) regulatory documentation
• Ability to ensure regulatory documentation complies with local Standard Operating Procedures (SOPs)
• Ability to manage strict deadlines and prepare for auditing activities
• Ability to maintain updated physician credentials and critical compliance documentation

Benefits:

• Comprehensive benefits supporting physical, mental, and financial well-being
• Competitive compensation package
• Annual bonus or long-term incentive opportunities may be offered
• Equity may be included in compensation
• Total Rewards package