Regulatory Affairs Manager

5 - 7 years experience  • 

Salary depends on experience
Posted on 04/19/18
Cincinnati, OH
5 - 7 years experience
Salary depends on experience
Posted on 04/19/18

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 affairsexperience, OR Master’s degree and 5 years regulatory affairsexperience;
  • 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.
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