Regulatory Affairs Intern – Regenerative Medicine Field
WHY ARMI? An internship within ARMI | BioFabUSA’s Regulatory Team is a great place for a student looking to experience the wide variety of interesting challenges that a regulatory professional may encounter in the cutting-edge field of tissue engineering and regenerative medicine. While a typical biotech firm may have a few products in the development pipeline, ARMI | BioFabUSA facilitates the collaboration of many individual organizations, each with diverse product types and in various stages of development. This aspect of ARMI | BioFabUSA grants Regulatory Interns a unique level of exposure not commonly experienced at a single firm in industry.
WHAT WILL I DO? The intern project for this semester is focused on advancing the regulatory education effort. Under the guidance of the Regulatory Team, the Intern will be responsible for researching a topical regulatory matter relevant to the TEMP product development process, and creating a brief presentation suitable for incorporation into an ARMI | BioFabUSA Regulatory Bootcamp session. The project will also include the design and execution of an interactive educational activity related to the chosen regulatory topic. The Intern will then have the opportunity to present their material and activity to ARMI | BioFabUSA staff. TEMP regulatory topics may include preclinical study design considerations, challenges specific to the regulatory pathway for complex biologics, navigating FDA interactions, or other areas of interest.
In addition to the Bootcamp effort, the Intern may have the opportunity to provide administrative support to the Regulatory Team during thought-provoking, confidential consulting sessions with various member-clients. These duties may include taking minutes, coordinating correspondence and scheduling, and relaying resources/follow-up information to member-clients after a call.
WHO SHOULD APPLY? The ideal Regulatory Intern candidate will have a scientific background, regulatory awareness, and most importantly, motivation to seek out knowledge from multiple sources and piece concepts together.
ABOUT ARMI: ARMI | BioFabUSA is a nonprofit organization which serves to advance the fields of tissue engineering and regenerative medicine. The organization is comprised of over 175 members, each with unique technologies related to the industry. ARMI’s mission is to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones.
The Regulatory Team within ARMI | BioFabUSA serves an important purpose in this effort. As cutting-edge technologies mature into novel medical products, the regulatory pathway and overall strategy to market can often be unclear. The Regulatory Team seeks to address this issue from multiple angles, such as: facilitating important early interactions with the FDA on behalf of consulting member-clients, assisting in the preparation of their regulatory submission documentation, making sense of historically broad regulations in the context of individual medical product development, and by increasing regulatory awareness and practical knowledge across the field through the development and hosting of interactive, educational Regulatory Bootcamp seminars.