Role Description We are seeking an experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory consulting organization. This is a high-impact leadership role focused on providing strategic regulatory guidance to biotechnology and pharmaceutical clients developing innovative and complex therapies. The successful candidate will serve as a trusted strategic advisor to clients pursuing late-stage development and commercialization of complex biologics, such as combination products, with a particular emphasis on US FDA regulatory strategy through BLA submission and approval. Experience supporting cell and gene therapies is highly desirable. In addition to technical regulatory leadership, this role requires strong client-facing skills, business acumen, and the ability to contribute to the growth of a boutique consultancy through thought leadership, client development, and industry engagement. Qualifications - Degree in a life sciences discipline - Significant industry experience - Deep expertise in US FDA regulatory strategy for biologics - Multiple successful BLA experiences with direct FDA interactions - Significant experience with complex modalities, such as combination products and cell and gene therapies - Strong consulting, leadership, communication, and presentation skills Requirements - Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management - Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics - Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy - Lead all aspects of health authority interactions - Support regulatory due diligence activities - Experience with EMA and other international health authorities is highly valued - Serve as a senior strategic advisor and primary client contact - Build long-term biotech and pharmaceutical client relationships - Lead multidisciplinary consulting teams and mentor junior staff - Deliver high-quality regulatory recommendations, reports, and presentations - Support business development, proposals, and client pitches - Represent the organization at conferences and industry events - Develop thought leadership materials and support company growth Company Description

• design, lead, and optimize HALO’s global supplier portfolio to improve margin, reliability, and speed-to-market • translate HALO’s growth strategy into a clear supplier vision • consolidate spend with strategic partners and expand capabilities in areas such as print-on-demand, point-of-sale, premium/recognition, and internal production • own end-to-end supplier performance, including economics, service, quality, compliance, and ESG alignment • build a high-performing team that partners closely with various departments • develop and maintain a multi-year supplier network strategy • lead consolidation efforts to drive a higher share of spend to top suppliers • build and manage a supplier scorecard framework to track performance • negotiate on commercial terms in partnership with Finance • partner with category leaders to build integrated supplier strategies

• Overseeing and optimizing data-driven initiatives • Making crucial technology decisions to enhance data infrastructure capabilities • Driving actionable insights and fueling organizational growth • Providing guidance and leadership in shaping long-term goals and objectives • Developing and executing plans that align with company mission, vision, and values • Ensuring effective and efficient resource utilization • Developing and executing data strategies that align with overall business goals • Overseeing design, development, and maintenance of scalable data models • Driving implementation and enhancement of ETL processes • Collaborating with cross-functional teams for data and analytics needs • Establishing and enforcing data governance policies and best practices • Monitoring data performance metrics and conducting regular assessments • Staying abreast of industry trends and emerging technologies • Identifying, developing, and implementing process or policy improvements • Developing and managing functional budgets

• Lead the Delivery Insights, Reporting, and Workforce Management functions to support operational performance, workforce effectiveness, and business decision-making across Service Delivery • Develop and deliver executive-level performance insights, reporting, and analysis that identify trends, risks, opportunities, and actionable recommendations to support operational and client success • Monitor operational metrics, including service level performance, quality results, productivity, staffing, attendance, adherence, occupancy, shrinkage, utilization, and client-specific KPIs • Lead workforce management activities, including forecasting, capacity planning, scheduling, real-time management, and workforce governance to ensure alignment with operational, client, and financial objectives • Lead reporting governance by establishing standardized reporting methodologies, dashboards, data quality controls, and reporting processes that support accurate and actionable business intelligence • Partner with cross-functional stakeholders to improve data quality, reporting automation, system adoption, reporting efficiency, and business visibility • Establish processes to identify, communicate, track, and resolve operational risks through trend analysis, root cause investigations, accountability frameworks, and performance improvement initiatives • Provide recommendations that support operational improvements, workforce effectiveness, client retention, customer experience initiatives, and business performance objectives • Lead the reporting and insights cadence for Service Delivery, including weekly, monthly, quarterly, and ad hoc business reviews • Collaborate with Service Delivery, Workforce Management, Quality Assurance, Client Services, Finance, Human Resources, Technology, and other stakeholders to align operational priorities and business objectives • Promote a culture of data-driven decision-making, operational accountability, and continuous improvement across the organization • Lead, coach, and develop leaders and team members while establishing performance expectations, accountability standards, and organizational capabilities in workforce optimization, analytics, reporting, and operational consulting • Adhere to company policies and procedures • Meet or exceed performance targets for related KPIs • Continuously improve knowledge of products, services, and processes by participating in training programs and continuous learning modules • Collaborate with other departments as needed • Maintain a positive, empathetic, and professional attitude toward customers and colleagues at all times • Perform other duties as assigned.