Pittsburgh, Pennsylvania, United States
Regulatory Affairs & Product Stewardship Leader | FDA Food Contact | Polymer & Engineering Resin Systems | Multi-Site Manufacturing Compliance I am a Regulatory Affairs and Product Stewardship professional with 30+ years of experience in polymer science, engineering resins, and global chemical compliance supporting the plastics and advanced materials industry. My work sits at the intersection of FDA food contact compliance, global chemical regulations, and manufacturing execution, where I help companies translate complex regulatory requirements into practical, scalable systems that support both operational performance and market access. I specialize in guiding organizations through multi-site regulatory alignment and product stewardship programs, including FDA food contact compliance (21 CFR 170–189), TSCA, REACH, RoHS, CEPA, and related global frameworks. A consistent focus of my career has been ensuring that compliance is not treated as a standalone function, but as an integrated part of product design, manufacturing consistency, and customer trust. Across roles at Covestro, PolyOne/Spartech, and other polymer manufacturers, I have supported: Multi-plant compliance harmonization across manufacturing and distribution networks FDA food contact evaluations, certifications, and regulatory submissions Customer-facing regulatory documentation and technical communication Risk reduction strategies for complex polymer formulations and additive systems Sustainability and recycled-content compliance considerations in packaging and plastics I have worked extensively with engineering thermoplastics, additives, compounds, and color/masterbatch systems used in demanding applications across packaging, industrial, and specialty markets. I am especially interested in environments where regulatory discipline directly supports manufacturing performance, product reliability, and customer success. My professional approach combines technical depth, structured regulatory thinking, and practical business alignment, with a focus on helping organizations reduce risk while enabling growth. I am particularly energized by opportunities to support multi-site manufacturing organizations in building consistent, audit-ready compliance systems that scale globally while remaining practical at the plant level.
• Delivered 125+ FDA food contact evaluations, 380+ EPA regulatory reviews, and 1,400+ annual global compliance responses supporting commercialization of polymer-based materials across industrial, packaging, and specialty applications • Supported cross-functional alignment between R&D, manufacturing, supply chain, and commercial teams to ensure regulatory compliance was embedded throughout product lifecycle and plant execution • Reduced regulatory cycle time by 50% through Lean Six Sigma methodologies, workflow redesign, and standardization of compliance decision pathways across global operations • Developed structured regulatory knowledge systems consolidating 40+ years of precedent into scalable, searchable frameworks to improve decision speed, audit consistency, and cross-site alignment • Partnered with manufacturing and quality teams to resolve compliance gaps, strengthen audit readiness, and ensure consistent documentation practices across global operations • Resolved 500+ complex technical inquiries spanning food contact, industrial polymer systems, and regulated applications requiring risk-based interpretation of global requirements • Authored and maintained audit-ready regulatory documentation supporting NSF compliance, customer requirements, and global product stewardship expectations
• Directed product compliance operations supporting global regulatory systems for product stewardship, supply chain assurance, and manufacturing-aligned documentation control • Translated complex FDA, TSCA, REACH, and CEPA regulatory requirements into scalable compliance frameworks supporting polymer, packaging, and industrial product commercialization • Reduced packaging approval cycle time by 50% at Mars Wrigley through end-to-end process redesign, improving regulatory throughput and cross-functional execution • Built centralized regulatory and chemical composition data systems enabling consistent product safety decisions across R&D, operations, and commercial teams • Led cross-functional standardization of workflows across Product, Operations, Quality, and Regulatory functions to improve consistency across distributed manufacturing environments • Conducted root cause analysis and corrective action planning to resolve compliance gaps, data integrity issues, and documentation inconsistencies • Provided regulatory interpretation and risk-based guidance across FDA, TSCA, REACH, and CEPA frameworks supporting global market access and manufacturing continuity
• Led global regulatory compliance and product stewardship activities across 39 manufacturing sites supporting engineered plastics, packaging, compounds, and specialty materials • Directed FDA food contact compliance programs for thermoformed PET and RPET packaging systems used in highly regulated applications • Enabled commercialization of sustainable packaging solutions through FDA-compliant recycled PET (RPET) strategies and risk-based regulatory assessments • Partnered with customers, manufacturing, R&D, quality, and commercial teams to support material selection, regulatory clearance, and successful product commercialization • Supported innovation initiatives balancing regulatory compliance, manufacturing capability, product performance, and cost optimization • Led ERP transition activities from Oracle to SAP, ensuring compliance continuity, specification integrity, and standardized documentation practices across multiple business units • Applied Lean Six Sigma principles to improve workflow efficiency, reduce process variability, and strengthen operational consistency • Developed governance frameworks, documentation controls, and compliance processes supporting long-term audit readiness and enterprise-wide regulatory consistency
• Supported material selection, technical compliance, and commercialization of high-performance engineering thermoplastics across medical, industrial, electrical, and transportation applications • Provided ISO 10993 biocompatibility support, regulatory documentation, and technical data packages for regulated product applications and OEM qualification activities • Partnered with OEM customers, design engineers, and manufacturing teams to secure material specifications and accelerate commercialization of engineered polymer solutions • Managed 137 OEM accounts including major global manufacturers such as Cisco Systems, Nortel, and Delphi Corporation • Closed 2.7 million pounds of engineering resin sales while developing a 35 million pound opportunity pipeline through technical solution selling and application development support • Supported demanding applications utilizing LEXAN™ (PC), CYCOLAC™ (ABS), CYCOLOY™ (PC/ABS), NORYL™ (PPO), and ULTEM™ (PEI) in environments requiring high heat resistance, dimensional stability, chemical resistance, and long-term durability • Conducted technical and regulatory risk assessments supporting material qualification, application reliability, and customer compliance expectations • Helped validate new distribution and customer engagement models that improved OEM access to engineering plastics and accelerated adoption across targeted markets
• Managed a multi-state technical sales and customer support territory serving OEMs, processors, and manufacturers across diverse plastics applications • Provided hands-on molding trial support, color development, processing optimization, and troubleshooting assistance for customer manufacturing operations • Supported material selection and application development activities balancing performance, manufacturability, aesthetics, and cost objectives • Partnered with production, quality, tooling, and engineering personnel to improve processing consistency and resolve manufacturing-related material challenges • Coordinated color matching, formulation adjustments, and customer qualification activities to support successful commercialization and production startup • Increased territory revenue by 6% through strategic account development, customer relationship management, and expansion of existing business opportunities • Built strong customer relationships by combining technical problem-solving with responsive commercial support in fast-paced manufacturing environments