Complex & Crucial: The World of Regulatory Affairs with Guest Liz Bloss
Fractals: Life Science Conversations
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Show Notes
Head of Regulatory Affairs, FDA communications expert, and Managing Partner: That’s Liz Bloss. Join us for this episode of Fractals: Life Science Conversations as we welcome Liz to the program. Liz brings a wealth of experience, from formulating early IND submission strategies to guiding companies through the complexities of NDA preparations. With a sharp focus on FDA communications and meeting readiness, Liz adeptly navigates milestone gatherings crucial for development program success. Her proficiency extends to maneuvering orphan drug submissions, providing US Agent support, and delivering invaluable regulatory feedback. Tune in to get the inside scoop on all thing regulatory from Liz, including:
- The significance of attentive listening and strategic pauses in achieving regulatory goals and fostering meaningful connections.
- Establishing communication channels between scientific and regulatory spheres to forge pathways with FDA or regulatory bodies.
- Understanding how regulatory affairs transcends paperwork and emphasizes the need for innovative interpretation and thinking outside traditional confines.
- Recognizing the importance of cultivating personal relationships, networking opportunities, and empowering women in the life sciences industry to foster an inclusive environment that embraces diverse perspectives.