Judith Macdonald is Senior Director, Global Regulatory Policy and Intelligence at Pfizer. Judith holds a B.Sc, (hons), in Microbiology from the University of Bristol UK and is responsible for regulatory science policy within the global regulatory policy and intelligence team at Pfizer. She has 30 years’ experience in global regulatory strategy where she oversaw the development and registration of multiple products both small molecule and biologics across a range of therapeutic areas with US FDA, EMA and emerging markets. In her current role she is dedicated to regulatory policy where she leverages her regulatory development knowledge and advocacy skills to help solve current regulatory challenges.
Judith represents Pfizer on EFPIA’s IMI regulatory support group and works with experts across the company on co-ordinating input into IMI.
She joined Pfizer in 2007 and has worked in regulatory strategy, public affairs and regulatory policy. In 2016 she moved into a dedicated regulatory policy role heading up the policy team for Pfizer’s essential health products including biosimilars. In January 2019 she became responsible for global policy development for Pfizer’s innovative product portfolio focusing on regulatory science advocacy and strategic communications.