North American Regulatory Expert

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.

• 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; and • Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.

• PhD in Life Sciences or PharmD • 6+ years of regulatory affairs experience in a CRO or Pharmaceutical industry