Robert Pietrusko

Biography

Robert Pietrusko is our Senior Vice President of Regulatory Affairs and Quality Assurance. He has three decades of experience in regulatory affairs and pharmaceutical drug development across a wide range of therapeutic categories, including CNS disorders and products governed by the Center for Biologics Evaluation and Research (CBER) of FDA. Dr. Pietrusko has directed the worldwide approval of more than 30 new products and new indications and is a recognized leader in the pharmaceutical industry having served as a BIO representative for PDUFA III and IV reauthorization negotiations with FDA. Before joining Voyager, Dr. Pietrusko was Vice President of Global Regulatory Affairs & Quality and an Executive Officer at ViroPharma, Inc. where he played a key role in the company’s acquisition and regulatory approvals of Cinryze, a plasma-derived orphan drug product for the treatment and prevention of angioedema attacks. Before ViroPharma, Dr. Pietrusko was Senior Vice President of Regulatory Affairs at Millennium Pharmaceuticals, where he directed the strategy and accelerated approval of Velcade in the U.S. and in more than 90 countries worldwide, including the centralized procedure in the EU. Prior to Millennium, he was a Vice President of Regulatory Affairs at SmithKline Beecham (now Glaxo SmithKline), where he led the submission and approval strategies for more than 30 NDAs, sNDAs, BLAs and MAAs in multiple therapeutics areas. Dr. Pietrusko is the author or co-author of 52 scientific publications. Dr. Pietrusko holds a Bachelors of Science in Biology, a Bachelors of Pharmacy from Rutgers University, and a Doctor of Pharmacy from the Philadelphia College of Pharmacy and Science. He completed his residency training in hospital pharmacy at Thomas Jefferson University Hospital.

Research Interest

science