Bayer: Regulatory Affairs


This 2-year US Regulatory Affairs Fellowship Program was developed by Howard University in collaboration with Bayer and the Food and Drug Administration (FDA). This is a comprehensive program designed to develop highly competent pharmacy professionals in regulatory affairs and policy. This fellowship program seeks to attract qualified candidates with a background in the field of pharmacy, such as PharmD degree holders, who wish to gain extensive training in regulatory affairs and policy. Candidates will have the opportunity to gain hands on experience in regulatory affairs and policy by working alongside FDA and industry professionals to address real-world challenges.


  • Lead and support interactions with FDA through the preparation of regulatory dossiers including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Clinical Trial Applications (CTAs), and Marketing Authorization Applications (MAAs)
  • Work with Global Regulatory Team members to develop regulatory strategy and guide Global Project Teams
  • Coordinate team activities to obtain written and oral Health Authority feedback on drug development and life cycle management topics.
  • Maintain marketed products to ensure compliance with regulatory requirements and optimal labeling.
  • Support U.S. Advertising and Promotion activities including promotional material reviews and FDA submissions.
  • Work with US CMC to develop strategy, submissions and maximize FDA interactions.
  • Exposure to Regulatory Intelligence and Analytics
  • Therapeutic Areas of Opportunity: US Regulatory Strategy in Cardiology, Nephrology & Thrombosis; Hematology; Ophthalmology; Pulmonology & Anti-infectives; Women’s Health Care; Cell & Gene therapy and Medical Devices (including Device Software and Mobile Medical Applications)
  • Fellow may also gain exposure to other areas of regulatory including: Oncology; Regulatory Policy
  • In the last six months of this fellowship, the successful fellow may have an opportunity to experience a rotation at the FDA in Regulatory Policy


  • Curriculum Vitae 
  • Letter of Intent 
  • Official Transcript 
  • 3 Letters of Recommendation 


Graduated with PharmD or Ph.D.