Robert is regulatory counsel in the firm's Product Liability Litigation practice group. He focuses his practice on regulatory and compliance matters involving the Food and Drug Administration (FDA) and has extensive in-house experience in the drug and medical device areas.
Robert’s experience includes leadership roles at small and large organizations within the pharmaceutical, biologics, medical device and food industries with onsite work in 14 countries. He has been accountable for regulatory affairs and compliance for preclinical studies, clinical trials, GMP, FDA pre-approval inspections (PAI) and FDA warning letter remediation. As department head, Robert has provided strategy and regulatory affairs support for R&D; implemented OIG-compliant health care systems; authored sections of INDs, NDAs, BLAs, 510Ks and SEC 10K annual reports; negotiated commercial contracts; led drug counterfeiting fraud investigations; and assisted with M&A transactions worth tens of millions of dollars. He has implemented U.S. Customs import/export compliance programs, GxP systems and policies for FCPA, anti-kickback, False Claims, SOX and Medicare compliance. Robert has also reviewed/approved hundreds of marketing materials for FDA/FTC compliance for print and television advertising campaigns.
Immediately prior to joining Thompson Hine, Robert was senior director of regulatory affairs at a multinational developer, manufacturer and marketer of medical products and services. He has served in regulatory, compliance and quality assurance leadership roles for a variety of pharmaceutical and medical device companies, ranging from startups to well-known global brands.
- “Medical Device Marketing Under Substantial Equivalence – FDA Clearance and USPTO Patent Consideration,” Regulatory Focus, Regulatory Affairs Professional Society, September 2018
- "Food and Drug Administration Enforcement,” Regulatory Focus, Regulatory Affairs Professional Society, June 2017
- “A View to Strategic Partnering,” Pharmaceutical Outsourcing, March 2017
- Contributor, “Roundtable: Regulatory and Revenue? How commercial and regulatory can achieve synergies,” Healthcare Sales & Marketing, February 2017
- “Regulatory Aspects of Contract Manufacturing,” Pharmaceutical Outsourcing, May 2010
- “Auditing CMOs and Developing Effective Monitoring Processes,” IQPC, Philadelphia, PA, December 2011
- “Contract Development & Management to Reduce Risk & Ensure Quality,” Brussels, Belgium, 2010
- Fellow, American Society for Quality
- American Society for Quality
- Regulatory Affairs Professionals Society
- Reviewer, Quality Progress Magazine, American Society for Quality, 2011-present
- Reviewer, ASQ Quality Press, American Society for Quality, 2011-present
September 01, 2018