Our clinical activities are growing rapidly, and we are currently seeking a full-time, Executive Director of US Regulatory Strategy to join our team. This position is 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 RAD possesses strategic leadership skills, has deep experience in North American (US and Canada) regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.
Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures and agency precedent.
Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.
Lead and support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables.
Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.
Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
Interact with appropriate national/regional government regulatory agencies; and
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
PhD in life science degree or PharmD
10+ years of regulatory affairs experience in a CRO or Pharmaceutical industry
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 approximately 3,500 people across almost 40 countries.