• Ensure global regulatory compliance and lead strategic initiatives • Guide regulatory activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics • Develop and implement regulatory strategies to support product development, registration, and lifecycle management • Provide strategic regulatory guidance, lead submission preparations, interact with regulatory authorities, and manage regulatory intelligence activities • Collaborate with Quality, R&D, Marketing, and other stakeholders to ensure regulatory requirements are met throughout product development and commercialization

• Manage and oversee OTS EPC projects during the pre-construction phase, including scope, schedule, and budget during pre-construction phase. • Maintain OTS Pre-Construction Tracker. • Act as main POC to EPC Pre-Con on all incoming projects. • Attend all BD to Pre-Con handoff calls. • Confirm initial project budgets and communicate with stakeholders. • Identify and manage cost changes during pre-construction phase. • Generate job start forms/setting projects up in CMiC. • Collaborate with design team in kicking off design in the constraints of project schedules. • Collaborate with procurement teams to draft project Bill of Materials (BOM). • Manage the execution of vendor subcontracts considering project schedule constraints. • Collaborate with EPC Pre-Con in processing SOLV-to-SOLV Agreements. • Track and review SOW exhibits. • Work with Manager, OTS Project Development and other Managers to assign appropriate project resources. • Review and update project schedules. • Participate in financial/month end reporting for projects during pre-construction phase. • Set up and host thorough project handoffs from OTS Pre-Con to OTS PMs. • Collaborate with EPC teams to process and import full project budgets into CMiC. • Support a culture of continuous improvement and look for opportunities to improve processes and efficiency.

• Serve as the day-to-day administrative execution lead for assigned Health and Public Safety projects. • Support large-scale, multi-partner initiatives with multiple concurrent deliverables and reporting requirements. • Develop and maintain detailed project trackers, timelines, and task management systems to ensure visibility into deliverables and deadlines. • Monitor progress across multiple concurrent workstreams and proactively follow up with team members, contractors, and partners to ensure commitments are met. • Structure and maintain documentation systems that support organized project execution and institutional continuity. • Coordinate and manage recurring project meeting cadence, including scheduling, agenda preparation, materials development, note-taking, action-item tracking, and follow-up. • Ensure meetings result in clear next steps and documented decisions. • Maintain continuity across meetings and workstreams to prevent duplication or dropped tasks. • Prepare clear and concise project summaries, status updates, and briefing materials for Health and Public Safety leadership. • Anticipate upcoming project needs and identify administrative or coordination gaps before they impact timelines. • Track grant-funded deliverables, reporting deadlines, and required documentation across multiple initiatives. • Process improvement opportunities to improve internal project tracking systems, documentation workflows, and administrative coordination processes.

• Lead multiple, concurrent acquisition and startup initiatives, ensuring full operational integration within the targeted timeframes. • Own the full project lifecycle—from initiation through closeout—ensuring execution excellence, risk and issue mitigation. • Develop detailed integration roadmaps and execution plans, ensuring clear milestones and stakeholder alignment. • Partner closely with various teams to identify gaps, risks, and required system/process changes. • Standardize and continuously improve integration playbooks and best practices to increase efficiency.