Senior Manager, Trade Compliance and Logistics

Job Overview

Sumitomo Pharma Co., Ltd. (Sumitomo Pharma America) seeks a Global Trade Compliance and Logistics Senior Manager to oversee U.S. customs and trade regulations, manage import/export compliance, drive continuous improvement, and serve as the subject‑matter expert for trade compliance.

• Support international movement of company materials, ensuring compliance with customs and regulatory agencies (CBP, FDA, USDA, CDC, BIS, Census, EPA, etc.) across all programs.
• Own U.S. trade compliance systems, policies, processes, and relationships.
• Develop, implement, and maintain company‑wide trade compliance programs, aligned with CBP and other regulatory requirements.
• Monitor new U.S. trade regulations, maintain compliance, integrate changes into operations and SOPs, and update management on impacts.
• Conduct internal import/export audits, support post‑entry audits, resolve discrepancies, drive corrections, reconcile or protest as needed, verify valuation methods, and ensure compliant record‑keeping.
• Lead enterprise trade compliance awareness and detail operational training.
• Assess and report transaction testing results, including compliance gaps and improvement opportunities.
• Facilitate customs clearance for new and escalated entries.
• Maintain trade classifications and country‑of‑origin determinations.
• Lead annual Customs Reconciliation activities.
• Oversee import/export security programs, including CTPAT.
• Advise management on trade developments, opportunities, and risk impacts.
• Lead continuous improvement in import/export activities, maintain current documentation, and recommend cost avoidance, duty mitigation, best practices, and corrective actions.
• Serve as SME on trade matters, including HTS classification, country of origin, valuation, denied parties, embargoes, duty/tax reduction programs, and red‑flag issues.
• Provide guidance on Incoterms, licensing requirements, and import/export schemes to support the global supply chain.
• Analyze and interpret complex trade compliance issues and data from multiple sources to make sound decisions and deliver effective business solutions.

• Assist in oversight of operations to move materials efficiently between CMOs, CPOs, 3PLs, Clinical Operations, and distribution centers.
• Proactively manage international transportation risks and develop mitigation strategies.
• Maintain compliance with international transportation regulations and pharmaceutical cold chain requirements.
• Coordinate shipments of API, intermediates, and finished goods.
• Promote and maintain GxP compliance across the network.

• Experience developing procedures and delivering education and workshops.
• Ability to collaborate across functions and communicate effectively at all levels.
• Ability to read and interpret government regulations.
• Ability to work independently.
• Highly organized in thought, communication, and execution.
• Ability to manage multiple projects and priorities.
• Curious, continuous‑improvement mindset that challenges the status quo.
• Work hours may include meetings outside normal business hours; peak periods may require additional time.
• Occasional domestic travel (~5%) may be required.

• Bachelor’s degree in business or a related field.
• 7+ years of logistics and trade compliance experience, including 5+ years in pharmaceuticals or a related industry.
• Knowledge of U.S. customs regulations, preferably for products under FDA authority.
• Experience with pharmaceutical HTS and ECCN classifications, valuation, country‑of‑origin determinations, and the CBP ACE portal.
• Experience with Customs Reconciliation, royalties, true‑ups, and assists preferred.
• Experience with the CBP CTPAT program.
• Ability to lead external partners, including customs brokers, customs counsel, freight forwarders, and parcel/courier providers.
• Working knowledge of GxP principles.
• Working knowledge of free trade agreements, foreign trade zones, and VAT/GST mitigation and recovery strategies.
• Participation in industry groups such as ICPA and AAEI.
• NCBFAA Certified Customs Specialist (CCS) certification preferred.
• Experience in…