Carla Sterk, MPharm
Executive Clinical Regulatory Strategist
Carla Sterk is a pharmacist by training and a registered Qualified Person (QP) with more than 30 years of experience in global regulatory affairs, including the last 11 years at Fortrea and its legacy organizations, Labcorp Drug Development and Covance. She previously held regulatory roles at large and mid-sized CROs and consultancy firms.
As an Executive Regulatory Strategist, Carla has extensive experience in global regulatory strategy for oncology products, supporting multiple development programs and regulatory agency interactions with the FDA, EMA and national competent authorities. Her experience includes resolving clinical holds, developing comprehensive development plans and target product profiles, securing orphan drug and expedited program designations and designing regulatory strategies for early access programs.
She has worked across a broad range of investigational products, including small molecules, biologics, biotech products and advanced therapies in oncology and other therapeutic areas such as immunology and dermatology, with experience in abbreviated and repurposed drug pathways.