Kenvue, Inc.

Regulatory Affairs Fellowship

 

Location: Summit, NJ
Not Recruiting for 2026-2027 Cycle

  

 

  • Develop a basic understanding of key FDA guidance documents and regulations for OTC products and apply thi knowledge to ongoing activities and projects
  • Support development and review of product labeling and artwork for accuracy and compliance with FDA regulations
  • Participate in promotional review for OTC drug products to ensure alignment with FDA regulations
  • Research key regulatory topics and become familiar with the external environment from a regulatory perspective
  • Understand the regulations for OTC drug products marketed under various pathways, i.e., OTC monograph, NDAs or ANDAs
  • Learn about FDA OTC monograph reform and support new innovation under the new OTC monograph system, as well and innovation for NDA products
  • Participate in the development of Regulatory strategies for new products in development and Rx to OTC switch projects
  • Provide support to the development of Regulatory submission packages to FDA for products marketed under NDAs and ANDAs
  • Apply knowledge and skills from academia and internships to support new initiatives and projects
     

Ifeoma Njubigbo, PharmD

First Year Fellow

University of Illinois-Chicago

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