Experience

Trinity Consultants - SafeBridge® Regulatory & Life Sciences Group

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Principal, Global Trade & Chemical Regulations Services

  • Jan 2020 - Present



The Redstone Group, LLC

• Chemical Manufacturing
• 1 - 100 Employee

• Director, Global Trade

  • Jan 2013 - Jan 2020

  Provide complete array of International Trade & Compliance and other regulatory guidance and services, including operations audits, compliance protocol design and implementation, audit & investigation support, government liaison services, product documentation, and transactional support. Clients range from Fortune 500 to smaller independent firms in the Chemical & Specialty Chemical, Pharmaceutical, Medical Equipment, Aerospace, and Industrial Equipment industries. Provide complete array of International Trade & Compliance and other regulatory guidance and services, including operations audits, compliance protocol design and implementation, audit & investigation support, government liaison services, product documentation, and transactional support. Clients range from Fortune 500 to smaller independent firms in the Chemical & Specialty Chemical, Pharmaceutical, Medical Equipment, Aerospace, and Industrial Equipment industries.



Edwin James, Ltd.

• International Trade and Development

• Principal

  • Jan 2002 - Jan 2013

  Performed and managed broad scope of International Trade & Compliance guidance and services, including operations audits, compliance protocol design and implementation, audit & investigation support, government liaison services, product documentation, and transactional support. Clients range from Fortune 500 to smaller independent firms in the Chemical & Specialty Chemical, Pharmaceutical, Medical Equipment, Aerospace, Industrial Equipment, Consumer Product, and Retail industries. Established international facilities; managed regulatory portfolios; served as principal liaison to US and international agencies; led transportation, product acquisition, and distribution contract negotiations; established transportation, logistics and supply chain operations; and added new international services to a variety of contract logistics providers and associations.



Pacer International

• Sr. VP & Division General Counsel

  • 1998 - 2002

  Chief legal officer delivering comprehensive leadership in legal services for the Global Logistics Division, with special emphasis on expansion of the company's international service portfolio and footprint. Chief regulatory counsel and international trade compliance officer for the company, and provided international trade compliance leadership and support for select recognized brand customers with multinational manufacturing presence. Chief legal officer delivering comprehensive leadership in legal services for the Global Logistics Division, with special emphasis on expansion of the company's international service portfolio and footprint. Chief regulatory counsel and international trade compliance officer for the company, and provided international trade compliance leadership and support for select recognized brand customers with multinational manufacturing presence.



Big Lots

• United States
• Retail
• 700 & Above Employee

• International Director, Legal Director, Assistant General Counsel, Assistant Secretary

  • 1989 - 1998

  Chief regulatory and commercial counsel, and corporate officer for global trade and regulatory compliance, with key leadership responsibility in expanding the international operating structure of the company. Comprehensive leadership in general corporate and commercial legal services with special emphasis on SEC and NYSE compliance and reporting, high profile negotiations and contracts (international & domestic), and FDA, DEA, BATFE and CPSC compliance. Chief regulatory and commercial counsel, and corporate officer for global trade and regulatory compliance, with key leadership responsibility in expanding the international operating structure of the company. Comprehensive leadership in general corporate and commercial legal services with special emphasis on SEC and NYSE compliance and reporting, high profile negotiations and contracts (international & domestic), and FDA, DEA, BATFE and CPSC compliance.



TNI BioTech (TNI Pharmaceuticals)

• General Counsel

  • 1985 - 1990

  General Legal Counsel with primary emphasis on FDA matters including preparing and filing IND/NDA, establishing clinical studies and trials and ongoing research studies; issues surrounding CDC and WHO related research and studies; grant and other funding procurement; and licensing pharmaceutical technology to major drug companies. Also led negotiations and SEC related compliance related to corporate fundraising, and directed corporate governance matters. General Legal Counsel with primary emphasis on FDA matters including preparing and filing IND/NDA, establishing clinical studies and trials and ongoing research studies; issues surrounding CDC and WHO related research and studies; grant and other funding procurement; and licensing pharmaceutical technology to major drug companies. Also led negotiations and SEC related compliance related to corporate fundraising, and directed corporate governance matters.



8181 Management Company

• Regulatory & Commercial Counsel

  • 1984 - 1988

  Business and Regulatory Counsel supporting managed medical research and health services centers, including affiliated medical technology incubator. Primary emphasis on FDA and other state and federal agencies concerning medical device and pharmaceutical research and development matters including preparing and filing PMA/PDP and IND/NDA, establishing clinical studies and trials and ongoing research studies; prosecuting device patents; grant and other funding procurement; licensing developed technology to major drug and medical device manufacturers; and compliance and commercial support for nuclear medicine practice including, device and supply procurement, including related NRC compliance. Secondary emphasis on SEC related support for financial investment groups surrounding medical technology development and commercialization. Served on Institutional Review Boards of managed entities.