Manager, Regulatory Affairs

Job Locations United States-OH-Cincinnati | United States-OH-Cincinnati
Category
Regulatory Affairs

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 approximately 3,500 people across almost 40 countries.

Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Affairs Manager to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Project management focus to facilitate full global regulatory submissions which will include:
    • Tracking, compiling, and maintaining full regulatory applications including initial INDs and NDAs;
    • Maintaining timelines for full regulatory submissions;
    • Providing regulatory advice and guidance to other Medpace department to ensure compliance with FDA regulations and requirements;
    • Interaction with FDA and other regulatory agencies;
    • Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the FDA; and
    • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

Qualifications

  • Bachelor’s Degree and 7 years regulatory affairs experience, OR Master’s degree and 5 years regulatory affairs experience;
  • Experience with FDA and other regulatory agencies is preferred;
  • Strong computer skills, project management skills, and a high attention to detail;
  • Strong communication skills (both written and oral); and
  • Must be a team player with a global regulatory mindset.
  • This position may require supervision of junior level staff.

 

Travel: Less than 10%

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.

 

Awards:

  • Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
  • 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.

 

EO/AA Employer M/F/Disability/Vets

2020-Top-Cincinnati-Workplace-Ribbon

*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.

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