Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Princeton
Posted on: January 25, 2023

Job Description:

Responsibilities:

• 
  
• Serve as a regulatory reviewer for assigned products. Ensure regulatory compliance while effectively managing business risks.
  
• Ensure that strategic regulatory subject matter expertise is provided on advertising and promotional materials/activities for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy.
  
• Review relevant medical and clinical development non-promotional materials in accordance with company policies.
  
• Direct the activities of regulatory personnel responsible for submissions of promotional materials to FDA.
  
• Monitor US regulatory promotional environment by staying up-to-date on FDA regulations and guidance, reviewing untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance at major FDLI, DIA, and other industry/FDA meetings (when appropriate).
  
  Requirements:
  
  
  • 
    
  • BA/BS Degree, Advanced degree preferable (MS, MD, PhD, PharmD, or JD).
    
  • Minimum 7 years regulatory experience.
    
  • Excellent understanding of US regulations for drug promotion/advertising and
    
  • experience in the regulatory review of prescription drug advertising and promotion including product launches.
    
  • Proven ability to provide strategic direction and innovative, forward thinking regulatory guidance and analyze and interpret efficacy and safety data.
    
  • Experience in leading activities necessary for promotional OPDP submissions.
    
    

Keywords: Katalyst Healthcares & Life Sciences, Trenton , Regulatory Affairs Specialist, Other , Princeton, New Jersey