Vice President, Regulatory Operations
With over 35 years of experience in quality assurance, regulatory affairs and compliance, combined with a legal background, Mr. Stoltman has a proven track record in identifying and solving difficult regulatory and compliance issues while providing efficient, value-added regulatory and quality assurance support. As Vice President, Regulatory Operations at Premier Consulting, he oversees the content and assembly of all FDA regulatory submissions, including intensive QA and validation of eCTD submissions.
Prior to joining Premier Consulting, Mr. Stoltman was the Director of Regulatory Compliance for Watson Laboratories (now Allergan) and was responsible for the site’s successful transition from a compliance remediation posture (consent decree) to commercial operation status. He was responsible for compliance across all site activities, including internal and external audits, management of all District and ORA FDA activities, including all inspections, review and approval of all data and documentation, annual product reviews, data trending and process optimization, change control, and complaint handling.
Mr. Stoltman has also held positions of Director of Quality Assurance and Regulatory Affairs Manager at Schwarz Pharma Manufacturing and was responsible for both the strategic and daily operations for four quality assurance sectors. Prior to Schwartz, he performed a similar role as Director of Regulatory Compliance and Director of Quality Assurance for Duramed Pharmaceuticals.
Mr. Stoltman holds a bachelor’s degree in Biology/Psychology from Drake University in Des Moines, Iowa, and earned his Doctor of Jurisprudence from the Indiana University School of Law in Indianapolis, Indiana. He has been a guest lecturer at the University of Cincinnati, School of Pharmacy on Regulatory Affairs and an invited speaker at NAPM (now AAM) on pre-approval inspections.
To learn more about Premier Consulting’s regulatory services & support, click here.