Senior Manager, Trade Compliance and Logistics

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. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

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.

Essential Functions Required for Job

Global Trade Compliance

• 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.

Logistics and International Transport Management

• 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.

Knowledge, Skills and Abilities (general & technical):

• 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, and peak periods may require additional time. Occasional domestic travel (~5%) may be required.

Education & Experience 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 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 international logistics, preferably in a pharmaceutical environment.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

• Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

• This is an individual contributor role and does not have direct reports or formal people‑management responsibilities.

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.