Experience

JMC NC INC

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Regulatory Affairs

  • Sep 2017 - Present

  Develop, implement and maintain processes to comply with U.S. Regulatory agencies for the importation of goods into the USA and the exportation to South and Central America. • Process all 161, 236 and 486 DEA applications, maintain record keeping standards, and create all written guidelines and procedures for DEA substances from inception to completion. • Audit all paperwork associated with DEA Controlled Substances to ensure compliance with JMC’s Compliance Program and all federal / state regulations and requirements applicable to controlled substances. • Responsible for our ISO 2015-9001 Program that includes all ISO Controlled Documentation such as SOP, Training, CAR, “Et Al”. Audit departments per ISO guidelines and encourage continuous improvement within each department. Work in tandem with ISO private Auditors to ensure processes, procedures and corrective revisions are adhered to for our ISO re-certification. • Oversee and participate in the review of products intended for import or export and verify control status in compliance with applicable governmental regulations for pharmaceutical and chemical compounds. • Proven analytical and organizational skills to research, interpret, document, problem-solve and communicate technical and non-technical information. • Expert in transportation-related technology, security, compliance and import/export operations • Manage third-party compliance service provider relationships by setting performance expectations and holding compliance service providers accountable for performance. • Manage compliance related projects Coordinate and negotiate with authorities. • Develop U.S. Freight Forwarder requirements and document a standardized operating procedure for all activities and services required to effectively perform import and export clearances. • Conduct monthly Compliance Trainings for the entire company (Import 101, Anti-Corruption/Anti-Bribery, TSCA, “Et Al”). Show less



CBC AMERICAS Corp

• Cary, NC

• Director of Logistics and Warehouse Operations

  • Aug 2010 - Sep 2017

  • Overseeing the daily operations and procedures of our 133,000-square foot warehouse and staff. Relocated a full stocked warehouse from NY to NC in October 2015 with an all new NC staff. Turned a failing warehouse with a cycle count ratio of 87% to a 99% accuracy cycle count. • Key member in crafting, developing, analyzing, mastering, and implementing a new software program for CBCA Corporation’s WMS. • Attend Monthly Board of Directors Meeting. • Manage the Logistics Department’s Air/Ocean importation, exportation, distribution, and Regulatory Compliance. • Controls the Company’s Global Compliance Program on an Executive level for their various locations with over 5,000 employees. • Work in tandem with our legal counsel on regulatory matters for our imports, exports & 3PL warehouse agreement contracts. • Review and implement cost reduction strategies & policies. • Interpret EAR for the processing BIS licenses and license exceptions. • Compose binding rulings for our pharmaceutical and chemical divisions for duty reduction or classification rulings. • Independently reviewing the company’s record keeping requirements for U.S. Customs and Border Protection. Incorporated the correct procedures for Regulatory Compliance for food/drug additives, BIS licensable products, chemical substances, APIs, CCTV goods & flooring material. • Orchestrating the design and implementation of our NEW profitable 3PL Division. Logistics Manager (2010 - 2015) CBC AMERICAS Corp., Commack, NY • Manager of the Logistics Department for the Air/Ocean importation/exportation, and distribution of our products. • Negotiated all air and ocean freight rates, trucking, and satellite warehouse pricing for our USA Headquarters, Italy, North Carolina, and west coast offices. • Created Import and Export Compliance Manuals. • Interacted weekly with DEA, FDA, and EPA on compliance matters, procedures, and releases. "ET AL" Show less



Star CNC Machine Tool Corp

• United States
• Machinery Manufacturing
• 1 - 100 Employee

• Commercial Department Manager

  • Jan 2005 - Jan 2009