Gregory_Rullo

Gregory Rullo

Executive Director, Regulatory Affairs-CMC, AstraZeneca

Greg Rullo is an Executive Director of CMC Regulatory Innovation at AstraZeneca and has a wide range of experience in the strategic and tactical aspects of pharmaceutical drug development and global regulatory CMC requirements. His duties include leadership in the use of modeling such as Physiological Based Biopharmaceutical Models, Machine Learning, and AI. He is also leading a document to data transition within CMC RA including delivery of future data centric submissions such as FDA’s PQ/CMC and Cloud=Based Submissions. He has extensive regulatory knowledge/experience of global CMC requirements with a detailed understanding of global submission requirements.

Appearances