• Lead the strategic evolution of Sabin’s QMS to support late-stage clinical development, licensure readiness, and future commercialization • Oversee and continuously improve eQMS, including document control, training, deviations, Corrective and Preventative Actions (CAPA), change control, risk management, management review, and supplier quality processes • Develop and maintain quality governance processes, quality metrics, and management review programs that drive compliance, transparency, and continual improvement • Lead implementation of Quality risk management principles consistent with ICH Q9 • Establish and maintain enterprise inspection readiness programs supporting sponsor audits, regulatory inspections, Bioresearch Monitoring (BIMO) inspections, and Pre-Approval Inspections (PAI) • Provide strategic oversight of supplier quality programs, including qualification, auditing, monitoring, and governance of Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), laboratories, and critical suppliers • Lead data integrity initiatives and ensure adherence to ALCOA+ principles across GxP systems and processes • Oversee investigations, deviations, change controls, CAPAs, and effectiveness verification activities • Partner cross-functionally with Technical Operations, Clinical Development, Regulatory Affairs, Supply Chain, and external partners to ensure phase-appropriate compliance • Support health authority interactions, inspection responses, and remediation activities, ensuring sustainable corrective and preventive actions • Promote a culture of quality, accountability, continuous learning, and operational excellence across the organization • Carry out other responsibilities as needed to support organizational priorities and public health goals.

• Serve as a member of the Commercial Leadership Team and contribute to the development and execution of the commercial, operational and organizational strategies and plans • Build a diverse and high performing team in the Commercial Excellence; integrate the cross-functional efforts of people and teams so that they work as collaborative partners with their peers • Build, activate, and optimize commercial capabilities to support excellence in planning and execution of sales, marketing, market access, and other functions as required. • Conduct business planning, forecasting, and performance monitoring, reporting and management capabilities that enable leadership to effectively manage the business and achieve its goals and objectives • Partner with Sales Leadership to ensure that the sales functions have the key enabling capabilities in place to achieve business performance objectives including, CRM/Dashboard, Reporting, Forecasting, and Incentive Compensation • Develop a world class Commercial Training and Employee Development function to ensure a knowledgeable go-to-market sales and sales support team • Define and manage the monthly, quarterly and annual forecasting process. • Develop and train on the supportive tools and templates; ensure that teams have the insights and data needed to make inform decisions • Lead of sales compensation team that will own sales incentive plan program including design for sales incentive plans, sales targets to meet annual plans, rules for plan participation, sales crediting, and payouts.

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