Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

 

Summary:

Responsible for global regulatory affairs strategy for assigned projects covering the development, registration and post approval phases, and acts as liaison with the health authorities including the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) review divisions and Office of Prescription Drug Promotion (OPDP), European Medicines Agency (EMA), and national authorities. Works closely with other functional areas to develop regulatory strategies and timelines, including regulatory operations, project management, translational sciences, clinical development, pharmacovigilance, legal, marketing, sales operations, and medical affairs.

 

REQUIREMENTS:

  • BS or MS degree in scientific, health care or related field or equivalent. 
  • A minimum of 10 years of pharmaceutical industry experience, with 5+ years of regulatory experience. 
  • Previous management experience is preferred. Must demonstrate the ability to work through others. 
  • Must demonstrate understanding of drug development and knowledge of FDA requirements. Working knowledge of scientific principles.
  • Direct experience with OPDP and marketed products preferred. 
  • Direct experience with FDA required and international experience preferred. 
  • Clinical Regulatory experience, not just IND experience
  • A leadership role on project teams with approximately 40% of time in meetings.