David Elder has been appointed as a Vice President to the Strategic Compliance Services team of Parexel Consulting, a business unit of Parexel International. Mr. Elder was a senior official at the FDA, where he served as the director of the Office of Regional Operations (ORO) within the Office of Regulatory Affairs (ORA), managing a team of professionals working around the globe to ensure that regulated products met the FDA’s standards, rules and regulations. Previously, Mr. Elder was Director of the Office of Enforcement within ORA. Prior to this position, he served in the FDA’s New England District Office as an investigator, compliance officer, and as director of the Compliance Branch.
During his 23 year tenure with the FDA, Mr. Elder was involved in domestic and foreign inspections, recalls and emergencies, and compliance actions involving hundreds of situations. He testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. As office director for both Enforcement and Regional Operations, he was a principal advisor to the associate commissioner of Regulatory Affairs at the FDA.
“The appointment of Mr. Elder to the Parexel team of regulatory and strategic compliance experts reinforces our commitment to help clients proactively manage the risk of potential safety issues and product delays and failures on a global scale,” said David L. Chesney, vice president and practice lead, Strategic Compliance Services, Parexel Consulting. “We expect that his extensive experience in conducting inspections and knowledge in areas such as global product safety and quality will greatly benefit our clients.”