• Manage submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities • Participate in submission team meetings • Coordinate multiple concurrent interrelated activities for submission projects for products in the delivery of published submissions within required timelines • Anticipate obstacles and develop solutions within the team • Coordinate submission publishing with publishers and provides notification to ensure all required resources are available to meet submission timelines • Prepare content planner for publishing and work with team members to resolve publishing issues • May perform publishing tasks • Assist with team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances

• Review medical education and commercial advertising and promotional materials to ensure compliance with applicable regulatory requirements • Serve as a regulatory reviewer on the Medical, Legal, Regulatory (MLR) committee and/or Medical Review Committee (MRC) teams • Assist with 2253 submissions • Monitor competitor space advertising and promotion materials • Provide strategic input on campaigns for compliant product communications • Identify MLR/MRC process or system improvements • Articulate complex regulatory issues to project teams and external stakeholders • Implement strategies to ensure programs are within the framework of published guidance documents • Assist with managing budgets for functional area • Develop relationships with external parties (e.g., CROs, consultants) and stay current on industry trends

• Support daily trade compliance operations in collaboration with external brokers, service providers and internal stakeholders • Develop, implement, and maintain standard operating procedures to ensure compliant import and export processes. • Analyze product data to evaluate and support customs and regulatory reporting requirements. • Interpret and apply the Harmonized Tariff Schedule (HTS) and other applicable tariff schedules, duties and partner government agency requirements to support Trek’s import and export activities. • Determine eligibility for preferential trade agreement treatment through analysis of rules of origin, bills of materials, and manufacturing processes. • Advise on country of origin determinations, marking requirements, and customs valuation principles. • Engage cross-functionally and with suppliers and vendors to collect, validate, and manage critical trade data. • Contribute to compliance process improvements and strategic initiatives. • Other projects and tasks as assigned.

• Oil spill response and vessel compliance specialist • Work with team members and clients to support client vessels’ day to day operations in U.S. waters and world-wide trade • Perform regulatory required filings and liaise with vessel Captains and client points of contact as well as various Federal, State, and local officials • Responsible for day-to-day administrative duties and supporting operations for regulatory compliance for commercial client vessel fleet(s) • Process electronic Notice of Arrival/Departure and Cargo Manifest filing (ACE/AMS) • Respond to oil pollution and vessel casualties on behalf of client as required • Participate in after hour’s duty rotation