Kenvue, Inc.

Regulatory Affairs Fellowship

Location: Fort Washington, PA
Not Recruiting for 2024-2025

• Develop a basic understanding of key FDA guidance documents and regulations for OTC products and apply this 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 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.