North American Regulatory Expert

Job Summary:Our clinical activities are growing rapidly, and we are currently seeking a full-time, Cincinnati-based Regulatory Expert to join our team. This position is responsible for the interactions with FDA, accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the team. The Regulatory Expert possesses strategic leadership skills, is experienced in North American (US FDA) regulatory science, and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to influence cross-functional discussions with Sponsors and relevant stakeholders.Responsibilities :Provide expert regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent;Advise project teams regarding the development and implementation of regulatory strategy through the clinical development processes;Collaborate with regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables;Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate;Interact with appropriate national/regional government regulatory agencies;Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges; andProvide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.Qualifications :PhD in Life Sciences or PharmD3+ years of regulatory affairs experience in a CRO or Pharmaceutical industryMedpace 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 weve 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 PerksCincinnati Campus OverviewHybrid work-from-home options (dependent upon position and level)Competitive PTO packages, starting at 20+ daysCompetitive compensation and benefits packageFlexible work scheduleCompany-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 programsAwardsNamed 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 compatibilityWhat to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.EO/AA Employer M/F/Disability/Vets