Regulatory Affairs Summer Intern-FDA Food

We are seeking a motivated and detail-oriented intern to join our Regulatory Affairs & Product Safety team. In this role, the intern will support a comprehensive assessment of product portfolios that may be affected by evolving FDA regulatory expectations related to Generally Recognized as Safe (GRAS) substances.

Working closely with the Senior Regulatory Affairs FDA Specialist, the intern will assist in developing and maintaining an inventory of substances, products, intended uses, and existing regulatory justifications. The intern will also participate in prioritization efforts by evaluating commercial significance, regulatory uncertainty, and the availability of supporting data.

As the project advances, the intern will help review substances, manufacturing processes, product specifications, intended uses, safety data, and supporting documentation to identify potential regulatory opportunities and risks. The intern will contribute to the development of recommendations regarding regulatory pathways, compliance strategies, and implementation priorities.

This project offers valuable exposure to regulatory strategy, risk assessment, data management, and regulatory compliance decision-making, providing a strong foundation in the practical application of regulatory affairs and product safety principles.

Key Responsibilities

• Support the evaluation and prioritization of a portfolio of products and substances potentially impacted by evolving FDA GRAS regulatory expectations.
• Develop and maintain a consolidated inventory of substances, products, intended uses, and supporting regulatory documentation to improve project visibility and decision-making.
• Review and organize regulatory information to improve the accessibility, consistency, and quality of product compliance documentation.
• Compile and summarize scientific, technical, and regulatory information to support the assessment of potential regulatory pathways and business impacts
• Identify opportunities to improve the efficiency of regulatory data management and documentation processes.
• Prepare written summaries and presentations communicating regulatory concepts and project findings to technical and non-technical audiences.
• Presentation at the end of the internship
• Other duties as assigned

Qualifications

• Rising sophomore or higher pursuing a degree in Chemistry, Biology or Public health.
• Available full-time in person (Mon–Fri) for our 12 week program
• Ability to follow safety procedures and maintain confidentiality
• Excellent communication and analytical skills
• Proficient in Microsoft Office
• Strong organizational and time-management skills
• Ability to work independently and collaboratively
• Eagerness to learn and take initiative