Manager – Global Import & Export Operations and Trade Compliance

Manager – Global Import & Export Operations and Trade Compliance

Requirements

• Bachelor’s degree, preferred in Business, Science or Law.
• Minimum 6 years’ experience in R&D material management/ clinical supplies/logistics, including 4 years’ experience in importing and exporting in a technical industry involving chemicals and controlled materials.
• Expert knowledge of the Export Administration Regulations (EAR).
• Knowledge and Ability to interpret EU, US and MERKOSUR Customs regulations and apply to Takeda businesses.
• Solid understanding of US Automated Export System via ACE.
• Export auditing experience
• HAZMAT Certification IATA and IMDG
• Export Compliance Officer certification
• License Customs Broker
• Well-developed supply chain knowledge
• Excellent communication, organizational, interpersonal, and writing skills and personal judgment
• Ability to work independently and exercise independent sound judgment
• Ability to clearly advise, explain and discuss material and complex matters with internal colleagues and external customers
• Ability to develop, present, and follow through on innovative solutions
• Must be a team player; ability to develop and utilize collaborative relationships
• Leadership skills – ability to lead and train cross-functional project teams.

Responsibilities

• Contribute to the creation and adherence of export and import compliance policies and procedures for the organization regarding Clinical Trial Material (CTM) and raw material shipments.
• Manage daily import and export transactions ensuring compliance to all US Government Laws and Regulations. This includes US Customs and Border Protection, USDA, FDA, Fish Wildlife, Public Health, Bureau of Industry and Security, DEA, FAA and possible other government agencies. This includes generating shipping documentation, working closely with the requester on specific to imports or exports.
• Ensure adherence to country specific standard operating procedures for importing/exporting clinical trial material and raw materials, including logistics, customs clearance and delivery cycle times.
• Liaise with in-country coordinators/CRO’s to establish standard import and export requirements for clinical trials, including export license determination.
• Help to maintain all international product data for development compounds: Country of Origin, Harmonized Tariff Codes, Export Commerce Control Number (ECCN), PGA Licenses & Permits, FDA product codes, INDs for raw materials, chemical intermediates, and finished goods.
• Instruct customs brokers and freight forwarders on how to handle the import/export transaction. Conduct post-entry review ensuring transactions comply with US import regulations.
• Provide guidance and valuation for non-commercial materials using WCO/WTO recommended best practices.
• Have proven experience identifying, forecasting and mitigating import VAT costs across multiple tax regimes.
• Identify key opportunities for process improvements and implement solutions to eliminate identified compliance deficiencies.
• Work closely with global colleagues in Clinical Supply Chain Operations and Legal to assure alignment of import and export compliance related activities within Takeda.
• Verify all international product data for CLINICAL AND RESEARCH AND DEVELOPMENT SUPPLIES: Country of Origin, Tariff Code/Schedule B, Export Commerce Control Number (ECCN), FDA product codes, NDAs, INDs for raw materials, chemical intermediates, and finished goods, are the ones determined and established by the Trade Compliance group.

Preferred Qualifications

• Export Compliance Officer certification
• License Customs Broker