Incyte

Regulatory Affairs Fellowship

Campuses: Chadds Ford, PA; Wilmington, DE
Recruiting: 1 Position for a 2-Year Fellowship

View Incyte Brochure

This two-year fellowship provides the fellow an opportunity to contribute to the development of strategies and plans to advance Incyte products through the regulatory review and approval process globally. Our growing, diverse portfolio provides a hands-on opportunity to learn and contribute to the development and delivery of products to address significant unmet medical needs. Throughout this program, the fellow will develop skills and gain experience in key regulatory functions to enable them to embark on a career within Regulatory Affairs.

The fellow will gain experience in the following key areas:

Regulatory Strategy

• Develop an understanding of federal laws, regulations, and guidance that form regulatory strategy
• Contribute to Investigational New Drug (IND) Applications, New Drug Application (NDA), Clinical Trial Applications (CTA), and postmarketing submissions
• Collaborate with cross-functional teams in the oncology and inflammation/autoimmune disorder portfolios

Promotional Regulatory Affairs 

• Develop an understanding of federal laws, regulations, and guidances that guide the promotion of prescription drugs and biologics for healthcare professionals and consumers
• Contribute to the development and review of healthcare professional and consumer marketing and educational materials, as well as contribute to the review of medical affairs materials
• Partner with marketing, medical affairs, and legal representatives during review of assets
• Assist with FDA submissions

Regulatory Labeling 

• Develop an understanding of regulations and guidance that steers the development of and updates to product labeling for healthcare professionals and patients
• Through engagement and collaboration with cross-functional subject matter experts, support the development and maintenance of the Company Core Data Sheet and local product labeling documents
• Contribute to the development of labeling tools and processes to expand the capabilities and efficiencies of the labeling team

Additional Experience

The Fellow will meet with other specialty areas in GRA, including CMC and Regulatory Operations, to develop an understanding of the contributions needed for small and large molecule development and regulatory submissions and systems.