Regulatory Affairs Project Manager Job Locations United States-OH-Cincinnati Category Regulatory Affairs Job Summary Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Project Manager to join our Cincinnati team! This person will be a key member of Regulatory Affairs project teams to accomplish tasks that are instrumental to the company's success. With this opportunity, you will be able to leverage previous expertise and continue to develop your career further within the drug development industry. Responsibilities Coordinate regulatory submissions and serve as the primary point of contact between Sponsors and US FDA; Coordinate Investigational New Drug (IND) application activities, track and report project status, and establish comprehensive program timelines; Schedule and lead internal and external project team meetings; Prepare agendas, presentation materials, and meeting minutes; Work closely with Regulatory Strategy Leads, Medical Writers, and Regulatory Document Specialists to execute project plans; Maintain clear and effective Sponsor communication, identify and anticipate possible issues and/or challenges, and work with the project team to develop solutions; Maintain close collaboration, interaction, and effective working relationships with Medpace functional area colleagues; Attend clinical operations internal meetings as the Regulatory Affairs representative; and Support other department initiatives as needed. Qualifications Bachelor's Degree in life sciences and minimum 2 years' regulatory experience or PhD in life sciences; Knowledge of the US FDA drug/biologic approval process; and IND application experience. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks Cincinnati Campus Overview Hybrid work-from-home options (dependent upon position and level) Competitive PTO packages, starting at 20+ days Competitive compensation and benefits package Flexible work schedule Company-sponsored employee appreciation events Employee health and wellness initiatives Community involvement with local nonprofit organizations Discounts on local sports games, fitness gyms and attractions Modern, ecofriendly campus with an on-site fitness center Structured career paths with opportunities for professional growth Discounted tuition for UC online programs Awards Named a Top Workplace in 2024 by The Cincinnati Enquirer Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace tea