Markas Marriott

Markas is a Senior Director at tranScrip, bringing 30 years of experience in Clinical Research and Regulatory Affairs across multiple sectors, including the Pharmaceutical/Biotech, Healthcare, and Consulting industries. Throughout his career, he has held leadership roles at renowned companies such as GSK, Baxter Healthcare, BASF, Shire, Icon, and PwC.

His regulatory expertise encompasses strategic consulting in Research and Development for Healthcare, Pharmaceutical/Biotech, and Advanced Therapy Medicinal Products (ATMPs). Markas has developed and executed regulatory strategy plans from early-phase research through to late-stage clinical development, regulatory submissions, and lifecycle management. His areas of focus include infectious diseases, anti-obesity treatments, neurology, rare diseases, oncology, respiratory conditions, and veterinary products, with experience in both drug and device development.

Markas’ functional area expertise spans a full spectrum of regulatory activities, including pre-approval strategies, submission activities, and post-approval maintenance. His experience covers CTAs/INDs, scientific advice, orphan drug designation, NDAs, MAAs, PiPs/iPsPs, and technical files. Additionally, he has extensive experience working with devices, combination products, small and large molecules, gene therapy development, and conducting due diligence in regulatory affairs and operations.

Before joining tranScrip, Markas served as a Global Regulatory Lead at GSK, where he drove regulatory strategies for clinical development assets in infectious diseases (HBV and women’s health) and respiratory conditions. He played a pivotal role in designing complex platform trials and advancing early paediatric development to accelerate product delivery to patients. Markas also has a strong background in consulting, having spent ten years in a senior role at ICON, where he contributed to business development, regulatory service expansion, and project delivery. Additionally, he spent three years at PwC in their Pharma practice, focusing on performance improvement consulting and change management as a regulatory SME involved in large-scale transformation projects.

His diverse career also includes leadership roles at SFL, Shire, Baxter, Knoll, Boots, and SmithKline Beecham. Markas holds an MBA, a Law Degree, and a degree in Biological & Biochemical Sciences with a focus on Regulatory Affairs. His comprehensive regulatory expertise spans a wide range of therapeutic areas and product types, making him a valuable asset to tranScrip and its clients.