Senior Manager, Trade Compliance and Logistics

Sumitomo Pharma•Marlborough, MA

1d•Remote

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. The Global Trade Compliance and Logistics Senior Manager ensures compliance with U.S. customs and other trade regulations by establishing, maintaining, educating on, and enforcing trade compliance policies and procedures in partnership with corporate and external counsel. This role oversees the compliant, efficient flow of imports and exports; supports key logistics and distribution activities; drives continuous improvement, scalability, risk mitigation, and cost savings; manages related systems and information in a GxP environment; and serves as SMPA’s SME for import and export trade compliance.

Requirements

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 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.
Excellent written and oral communication skills required.
Ability to use a personal computer for extended periods of time.

Nice To Haves

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.
Experience with Customs Reconciliation, royalties, true-ups, and assists preferred.
Participation in industry groups such as ICPA and AAEI.
NCBFAA Certified Customs Specialist (CCS) certification preferred.
Experience in international logistics, preferably in a pharmaceutical environment.

Responsibilities

Support international movement of company materials by ensuring compliance with customs and other import/export regulatory agencies, including CBP, FDA, USDA, CDC, BIS, Census, EPA, and F&W, across commercial, clinical, R&D, and other programs.
Own U.S. trade compliance systems, policies, processes, and internal/external relationships.
Develop, implement, and maintain company-wide trade compliance programs, policies, procedures, and controls 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 recordkeeping.
Lead enterprise trade compliance awareness and detailed 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 the 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, as applicable.
Coordinate shipments of API, intermediates, and finished goods.
Promote and maintain GxP compliance across the network.