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Regulatory Affairs Project Manager - PhD in Life Science Field Career Opportunit Job in Cincinnati, Ohio US

Job Summary

Medpace, Inc.
Cincinnati, OH
Government and Military
Job Type
Full Time
Years of Experience
Less than 1 Year
Job Reference Code

Regulatory Affairs Project Manager - PhD in Life Science Field Career Opportunit

About the Job

Regulatory Affairs Project Manager - PhD in Life Science Field Career Opportunity

Job Locations

United States-OH-Cincinnati


Regulatory Affairs


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.

Job Summary

The Regulatory Affairs Project Manager position at Medpace offersthe unique opportunity to have anexciting careerin the research of drug and medical device development whilemaking a differencein the lives of those around them. For those witha PhD in a life science field who want to explore the research field and be part of a team bringing pharmaceutical and medical devices to market -this could be the right opportunity for you!


Manage multiple projects while ensure timely completion of tasks and overall completion;
Manage IND and NDA project deliverables and timelines;
Maintain timelines for components of regulatory deliverables;
Prepare regulatory documents for submission to the FDA, including writing, publishing, correct placement in eCTD hierarchy;
Conduct meetings with internal teams, Sponsors, and FDA as needed, including meeting agendas, minutes, action items;
Maintain Regulatory records, including archive of submissions and FDA correspondences files;
Ensure submissions comply with applicable regulations and guidance documents;
Advise clients on regulations as they apply to IND and NDA development;
Prepare and deliver regulatory submissions to domestic and international regulatory agencies and scientific advice bodies;
Perform document quality control checks in accordance with established processes;
Provide day-to-day department support activities to aide completion of project deliverables;
Maintain up to date knowledge of regulatory requirements, guidance, and science; and
May be responsible for other projects and responsibilities as assigned.
In Europe, assist in assessment of dossiers for regulatory applications from a technological/biopharmaceutical perspective;


PhD in a life science related field or PharmD
Strong computer skills, project management skills, and a high attention to detail; and
Strong communication skills (both written and oral).

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.


Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
Recognized by Forbes as one of America's Best Mid-size Companies in 2021
Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

*WARNING:Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.

EO/AA Employer M/F/Disability/Vets

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