Executive Director of US Regulatory Strategy
Cincinnati, OH 
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Posted 3 days ago
Job Description
Executive Director of US Regulatory Strategy
Job Locations United States
Category Regulatory Affairs
Job Summary

Our clinical activities are growing rapidly, and we are currently seeking a full-time, Executive Director of US Regulatory Strategy
to join our team. This position is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the team. The RAD possesses strategic leadership skills, has deep experience in North American (US and Canada) regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.

Responsibilities
    Provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures and agency precedent.
  • Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.
  • Lead and support regulatory and broader development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables.
  • Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.
  • Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
  • Interact with appropriate national/regional government regulatory agencies; and
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
Qualifications
  • PhD in life science degree or PharmD
  • 10+ years of regulatory affairs experience in a CRO or Pharmaceutical industry
Medpace 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.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Today

The work we've done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Celebrates 30 Years

As we celebrate 3 decades of industry expertise and organic growth, we recognize the global team responsible for driving clinical development at Medpace. Click here to learn more about Medpace Celebrating 30 Years.

Medpace Perks

  • Hybrid work-from-home options (dependent upon position and level)
  • Competitive PTO packages - starting at 20+ days
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Wellness rooms and huddle rooms
  • Flexible work schedule
  • Competitive compensation and benefits package
  • Structured career paths with opportunities for professional growth
  • Discounts for local businesses

Awards:

  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021 and 2022
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.


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Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Doctorate
Required Experience
10+ years
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