FDA Regulatory Expert

				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.

Responsibilities:

* Provide expert regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent;
* Advise sponsors and project teams regarding the development and implementation of regulatory strategy throughout the clinical development processes; and 
* Collaborate with cross-functional teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables.

Qualifications:

* MD, PhD in Life Sciences, or other advanced degree.
* Minimum of 5 years of experience or equivalent of regulatory drug development. Expert knowledge of regulatory affairs within one or more therapeutic areas; and
* Professional experience working at the FDA such as Medical Reviewer, Clinical Team Leader, or Division Director, preferred.
			

Apply

Share this job:

Share this Job

View company profile

Medpace, Inc.

Connect To Our Company