Anita Lalloo is a Director in Global Regulatory Affairs - CMC at Merck. She is responsible for developing global CMC regulatory strategies that are aligned with major and regional regulatory requirements. To promote innovation in Regulatory Sciences, Anita provides regulatory guidance for several novel initiatives including continuous manufacturing, 3D printing, accelerated pharmacokinetic studies (APKS) and patient centric specifications. She has led several discussions with regulatory agencies to understand the regulatory environment and explore options to drive innovation and flexibility in manufacturing. Anita represents Merck through EFPIA on the ICHQ13 draft guidance on Continuous Manufacturing.
In her previous role, in the Global Technical Operations at Merck (MSD), Singapore, Anita was responsible for ensuring reliable product supply, leading product/process investigations, identifying and driving manufacturing process improvements and supporting post approval changes and site inspections.
Anita started her career in formulation development more than 15 years ago, focusing on predicting clinical performance of formulations using in vitro, preclinical and model and simulation tools. Her experience spans all phases of drug development through to commercial manufacturing site experience. She received her Ph.D. in Pharmaceutical Sciences from Rutgers University.