Ben Kaspar Email & Phone Number

I am an experienced regulatory lead and director with a passion for strategy and the capability to manage multiple development programs at all stages and across regions. My approach is highly collaborative and cross functional with 15 years of experience extending beyond strategy into operations, pharmacovigilance, data science and compliance. I am a team player who enjoys forging strong relationships with internal teams as well as clinical CROs and other vendors. My background is in medical writing, thus my approach to regulatory affairs is centered on strong writing and effective, timely communication. I emphasize concision, and consistency across the eCTD with a focus on scientific arguments and current Health Authority approaches to risk/benefit. I enjoy the challenge of harmonizing strategy across multiple Health Authorities, particularly at the proof of concept, end-of-Phase 2 and pre-NDA/MAA stages. I am also familiar with regulatory challenges inherent in multinational trials, including management of transparency requirements, information requests, and varying regional protocol amendments. I bring a strong focus on regulatory intelligence and enjoy challenging my teams to think critically about precedent, guidance, and law as they apply to their unique project challenges.

Listed skills include Writing, Protocol, Reviews, Regulatory, and 6 others.