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 regulatory agencies (eg, US FDA);Coordinate Investigational New Drug (IND) application activities, track and report project status, and establish comprehensive program timelines;Plan and lead internal and external project meetings, including preparing agendas, presentation materials, and meeting minutes;Collaborate with Regulatory Strategy Leads, Medical Writers, Regulatory Document Specialists, and other Medpace functional areas 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; andSupport other department initiatives as needed.Qualifications Bachelor’s Degree in life sciences and minimum 2 years’ regulatory experience, or PhD in life sciences with applicable regulatory knowledge; Experience working with or submitting to the US FDAKnowledge of FDA regulations and the IND application process;Knowledge of clinical drug and biologic development;Strong organizational, communication, and project management skills; andAbility to thrive in a fast-paced, collaborative environment. 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 OverviewFlexible work environmentCompetitive PTO packages, starting at 20+ daysCompetitive compensation and benefits packageCompany-sponsored employee appreciation eventsEmployee health and wellness initiativesCommunity involvement with local nonprofit organizationsDiscounts on local sports games, fitness gyms and attractionsModern, ecofriendly campus with an on-site fitness centerStructured career paths with opportunities for professional growthDiscounted tuition for UC online programsAwards
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 2024Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.