• provide regulatory submission publishing services in an efficient and timely manner • key point of contact for all customers of the Regulatory Operations group • uphold “right first time” submission quality and timeliness • liaison with Regulatory Affairs and local affiliates for support • work with counterparts in other regions to facilitate global worksharing • provide best practice guidance within Submission Publishing and Document Management • provide guidance to junior staff members • support projects related to improving publishing tools, standards, and processes • monitor agency guidance & changing regulations in assigned region

• Support day-to-day U.S. import compliance activities in accordance with CBP and applicable PGA requirements • Review and approval of import documentation, HTS classifications, valuation, country of origin, and end-use documentation • Review, audit, and maintain import documentation, including commercial invoices, packing lists, customs entry records, and FDA-related import documentation • Coordinate and communicate with customs brokers, freight forwarders, carriers, and internal stakeholders to ensure timely customs clearance and delivery • Monitor international shipments and proactively resolve customs clearance or transportation issues • Assist with HTS classification and country-of-origin determinations by coordinating with internal stakeholders and external trade compliance resources as needed • Support import audit readiness and compliance reporting activities • Ensure compliance with FDA, USDA/APHIS, Fish & Wildlife Service, and other PGA import requirements • Track logistics and import compliance metrics, shipment status, transportation performance, and broker KPIs • Partner with Supply Chain, Procurement, Finance, Quality, Regulatory, and external logistics providers to improve operational efficiency • Support and lead process improvement initiatives related to trade compliance and logistics operations • Support commercial launch activities involving FTZ operations, FDA import coordination, and temperature-controlled international shipments.

• Administer federal contracts and subcontracts throughout the lifecycle, including pre-award, post-award, modifications, and closeout. • Review solicitations, contract documents, and subcontract agreements to identify risks, reporting requirements, compliance obligations, and flow-down provisions. • Prepare, review, and administer NDAs, teaming agreements, subcontract agreements, purchase orders, and professional services agreements. • Manage subcontract administration activities including change management, deliverable tracking, subcontractor coordination, and records retention. • Collaborate with program managers, finance, procurement, and operations to support contract administration, proposals, pricing, and regulatory compliance. • Assist the Federal Pricing Manager with pricing templates, labor category mapping, subcontractor quote coordination, and estimating support. • Maintain contract files, subcontract records, tracking logs, and documentation per company and federal requirements. • Support GSA Schedule updates, contract reporting, and company registrations as needed. • Support implementation and maintenance of federal contract compliance policies and procedures. • Assist with internal compliance reviews, audit readiness, and responses to government audits and customer assessments. • Coordinate DOD and DOE contractor security requirements and facility clearance administration. • Maintain personnel security, facility clearance, and contractor compliance documentation. • Assist with administrative coordination of CMMC compliance activities in collaboration with the managed enclave provider and internal stakeholders. • Organize and maintain compliance artifacts, policies, procedures, and cybersecurity audit documentation. • Coordinate contractor reporting requirements, certifications, and related regulatory compliance activities.

• Provide day-to-day support for AgileLoft users, including content routing, workflow management, and issue resolution • Assist with setup and maintenance of review workflows, user roles, and permissions • Troubleshoot submission, approval, and annotation issues within MLR processes • Support content lifecycle management, including versioning, tagging, and archiving • Partner with Marketing, Medical, and Legal teams to ensure timely review cycle completion • Administer and maintain ComplianceWire training assignments, curricula, and user records • Support onboarding/offboarding activities and training compliance tracking • Troubleshoot user access, training completion, and reporting issues • Generate and distribute compliance reports for audits and internal stakeholders • Ensure training records align with regulatory and audit requirements (GxP, FDA, etc.) • Serve as first-line support for system-related inquiries and escalate issues as needed • Maintain system documentation, SOPs, and job aids • Support data integrity, validation activities, and audit readiness efforts • Collaborate with IT, QA, and vendors for system enhancements and issue resolution • Monitor system performance and proactively identify improvement opportunities