Lwin Mar Htun

WORK HISTORY

EDUCATION

ABOUT LWIN MAR HTUN

I’m a Regulatory Affairs Manager and UK-based Subject Matter Expert (SME) for Medical Device application and registration with over 7 years of experience across clinical research, regulatory operations, and medical device development. My career spans start-up through to regulatory strategy, with a strong focus on delivering compliant, efficient, and patient-centric solutions in both global pharma and CRO environments.Currently, I lead regulatory activities and study start-up efforts, supporting global sponsors in navigating complex regulatory environments. My recent work includes driving submission strategies for Class II and medical devices. Notably, I was one of the first team members involved in Gilead’s real-world solutions initiative during the COVID-19 pandemic in 2020 for Remdesivir Trial. This high-impact project supported the rapid deployment of vaccine research infrastructure — a pivotal moment that deepened my commitment to scalable, ethical research strategies.My foundation includes 7+ years in Project Management, Regulatory Affairs and Clinical Site Set-up, and 5+ years in e-commerce, marketing, and IT systems, equipping me with a data-driven mindset and strong capabilities in tools like SQL, CRM systems, and digital process optimisation. I bring a dynamic, assertive, and collaborative approach to every project, balancing regulatory rigor with operational agility.