In this episode, Aaron Einhorn takes us on a journey through the rigorous FDA drug approval process, discussing two potential game-changers—one gearing up for Phase 2 trials and another on the cusp of Phase 3. We'll explore the intricate dance of strategizing for approval while keeping patient benefits at the forefront.

But it’s not all test tubes and trials; Aaron shares his personal trajectory from a hands-on role in gene regulation therapy and antibody development to his current remote-driven position in regulatory affairs at Resolute Bio. His experience is rich—spanning academia at Loyola University Health Center and further learning at Northwestern University before diving into the biotech startup scene.

As we navigate the complexities of Aaron's day-to-day, he unfolds the intricacies of orchestrating communication across departments and demystifies the role of contract research organizations (CROs) in our current landscape. Moreover, we uncover how remote work tools, such as Teams, SharePoint, and the project management software Smartsheet, are the gears that keep the machinery of remote regulatory affairs running smoothly.

Our conversation also touches on the vital importance of leadership without borders, the nuances of managing timelines against the backdrop of lengthy drug trials, and the growth of remote opportunities in the pharmaceutical and biotech industry.

Aaron's commitment to professional development shines through as he preps for a certification test with the Regulatory Affairs Professional Society and gears up to network at the RAPS Convergence conference in Montreal.

Aaron Einhorn began his career journey in an academic research lab, where he delved into the complexities of handling clinical samples. With an aspiration to transition from academia to the bustling industry scene, Aaron knew that further education was his gateway. Pursuing this goal with determination, he earned his Master of Science in Biotechnology from Northwestern University, broadening his horizons and gaining proficiency in diverse aspects of biotechnology.

00:00 Clinical researcher successfully transitioned to remote work.

05:11 Interacting with various organizations for clinical work.

08:01 Using Office 365 suite, Teams, SharePoint, Smartsheet.

12:19 Not managing directly, but influencing team coordination.

16:22 Phase three trial evaluates safety and efficacy.

19:24 Nucleotide therapies evolved with mRNA vaccine development.

20:36 Regulatory work is great for science background.

27:08 Biotech and pharma funding increasing, remote work.

28:58 Joining RAPS for regulatory affairs certification preparation.

34:06 Seek remote work you're interested in, wisely.

37:06 Resolute values remote work but sees the value in in-person interactions.

38:20 Remote work has been great for me.