Thelma Marley
Thelma Marley, Associate Director, Strategic RA, Aerogen
Thelma Marley is Associate Director of Strategic Regulatory at Aerogen Ltd., where she also serves as the Management Representative and holds PRRC responsibilities. Leading Aerogen’s Biocompatibility division and deeply involved in the evolution of design and development and post-market activities, Thelma brings over two decades of experience shaping regulatory strategies and driving regulatory and quality compliance across global markets. Thelma’s expertise spans multiple device classifications, including general medical devices, active devices, and, more recently, drug–device combination products.
In her role as device lead for the Aerogen Pharma program, Thelma will support phase III clinical trials and guide the device regulatory strategy toward both Biological License Application (BLA) and CE marking. Thelma also leads device regulatory strategies for other drug-device partnerships in Aerogen. She is committed to developing robust regulatory strategies and fostering collaborative, cross-functional partnerships that enable successful business outcomes. An experienced audit lead and participant in regulatory agency inspections, she has overseen global product registrations that support both business continuity and market expansion.
Thelma also oversees the monitoring and dissemination of global regulatory intelligence, ensuring Aerogen maintains world-class compliance practices and actively contributes to MedTech working task forces.
Thelma holds an MSc in Medical Technology Regulatory Affairs. She recently co-authored a peer-reviewed paper with Dr Olivia McDermott and Deirdre Barrow, titled “Global Market and Supply Chain Implications of the European Union Medical Device Regulation 2017/745 as amended by 2023/607,” accepted for publication in BMC Health Services (a Q1-ranked journal). This research explores the evolving EU MDR landscape and its global market and supply chain impact, issues of increasing importance to regulatory strategy worldwide.