Regulatory Affairs Project Manager

				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:

* 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; and
* Support 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 FDA
* Knowledge of FDA regulations and the IND application process;
* Knowledge of clinical drug and biologic development;
* Strong organizational, communication, and project management skills; and
* Ability to thrive in a fast-paced, collaborative environment.
			

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Medpace, Inc.

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