• Working with clients and CBP to resolve CBPF 28 Requests for Information and CBPF 29 Notices of Action • Filing PSCs, tenders of duty and protests • Crafts petitions and facilitates payment of Liquidated Damages and Penalty Cases • May file reconciliation entries • Fields FTA inquiries (mainly USMCA) and works with staff on FTA claims • Advanced HTS classification • Works with CBP and clients to file prior disclosures • Maintains and develops client relationships • Acts as a compliance resource to Deringer’s various offices and departments • Drafts communications and responds to correspondence • Ensures compliance with Deringer specific policies and procedures, based on department’s specific tasks • Reviews Federal Register, CSMS Messages, and International Trade Publication (ITT) daily, analyzes regulatory changes and reports finding to the departments’ leadership • Researches binding rulings, summarizes finding and applies conclusions to questions presented by external and/or internal clients; reports finding to departments’ leadership for next level review • Conduct basic legal and regulatory research and presents findings in a professional manner • Proactively and timely coordinates dissemination of information obtained from customs publications, projects and research back to operations including other locations; this involves interrogating Deringer’s systems to understand who needs the information • Run ACE reports and reports from internal systems and organizes and presents data • Performs calculations, reconciliations, analyzes reports, researches, and tracks and troubleshoots • Assembles relevant data; compiles statistics and information as directed • Pursues new sales’ leads; discusses and sells the Company’s services to current clients and promptly forwards potential leads to designated person (soft selling) • Stays up-to-date on regulations, laws, guidelines and Deringer requirements • Acts as a resource to internal and external clients • Acts as liaison with other departments and outside agencies • Handles confidential and non-routine information • Facilitates projects of various scope and size • Writes or provides presentation on a wide variety of topics • Resolves problems (i.e. billing, tracing shipments) and handles customers’ concerns • Build relationships with customers • Performs other tasks as assigned by supervisor • May require occasional travel (less than 10% of time)

• Reviews and analyzes customs forms CF 28 (Request for Information) and CF 29 (Notice of Action) • Conducts entry audit, and runs reports to determine the full scope of the issue covered by the CF28/CF29 • Identifies other clients who may be affected • Generates and analyzes ACE data reports and internal system reports related to customs compliance and regulations • Proactively identifies errors in entries and compliance issues through reporting and analytics, proposes corrections and process improvements • Works with Deringer’s operations team and auditors to address the issues and implement preventive procedures • Collaborates with corporate/regional auditors and conducts internal audits to assess customs compliance and regulations • Collaborates with Regulatory Affairs to develop and implement trade and compliance procedures • Evaluates and analyzes Free Trade Agreements for validity • Conducts FTA eligibility analysis • Provides recommendations for improvement and cost savings initiatives • Identifies and mitigates compliance related risks

• Works collaboratively with implementation and support teams to ensure client business and clinical requirements are accurately captured and addressed throughout the implementation process and beyond. • Serves as a subject matter expert on clinical best practices and health plan regulatory compliance, ensuring that ZeOmega’s solutions align with industry standards and meet client needs. • Focuses on enhancing the end-user experience by promoting usability and workflow efficiency.

• Defining, coordinating and implementing global CMC regulatory strategies for product specific development and life-cycle activities • Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets • Liaising directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters • Negotiating with regulatory authorities during the development process to ensure submission acceptance and approval • Managing the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives • Advising on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with business needs and goals • Facilitating the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders • Identifying and recommending the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations • Collaborating with key functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs • In collaboration with the network strategist, developing and managing timelines supporting regulatory submissions, proactively identifying risks and developing adequate risk management solutions in consultation with cross-functional teams