• Own customer implementations from contract signature through go-live and post-implementation transition. • Lead complex enterprise healthcare technology deployments involving multiple stakeholders, integrations, and workstreams. • Build and scale implementation methodologies, governance processes, tools, and delivery standards. • Partner closely with Product, Engineering, Sales, Customer Success, and Support teams to ensure successful customer outcomes. • Serve as the executive escalation point for implementation risks, issues, and customer concerns. • Establish implementation KPIs, capacity planning processes, and delivery metrics. • Recruit, mentor, and develop implementation team members while maintaining direct involvement in strategic deployments.

• Lead and develop a set of managers running multi-disciplinary teams of project managers, implementation consultants, and technical staff across healthcare product lines • Set team strategy for project planning, staffing, and resource allocation across concurrent NetMenu and Quickcharge engagements • Ensure the team delivers professional services to healthcare clients, meeting established goals for utilization, revenue, and customer satisfaction • Guide implementation teams through the complexity of clinical environments, including EHR integrations (e.g., Epic/HL7), diet order workflows, and healthcare payment systems • Serve as a mentor and escalation point internally and externally; step into a client-facing role for strategic accounts to ensure satisfaction • Partner with Sales, Solution Engineering, and Client Management to ensure successful sales and implementations, where expectations are properly set around delivery timelines, scope, and readiness • Establish and manage third-party partnerships to supplement core staff during peak periods • Drive process improvement and efficiency gains across the team’s delivery model, with particular attention to the regulatory and patient safety demands of healthcare environments

• Provide required physician supervision for nurse practitioners in accordance with state regulations in Georgia • Conduct quarterly (at minimum) virtual meetings with supervised nurse practitioners to: • Review clinical cases • Provide guidance and mentorship • Ensure adherence to clinical protocols and standards of care • Perform periodic chart reviews and quality assurance checks • Be available on an as-needed basis for clinical consultation • Collaborate with clinical leadership to support: • Ongoing quality improvement initiatives • Protocol development and updates • Compliance with regulatory and payer requirements • Maintain appropriate documentation of supervisory activities as required by the state

Role Description As a member of the Regulatory Affairs organization, you will play a critical role in advancing innovative oncology therapies from development through registration and commercialization, helping bring transformative medicines to patients worldwide. The Associate Director, Regulatory Affairs Japan will serve as the regulatory lead for assigned development programs and products in Japan. This individual will be responsible for developing and executing regulatory strategies to support clinical development, registration, and lifecycle management activities. The role will represent Japan Regulatory Affairs on global project teams, contribute to PMDA interactions, and provide strategic regulatory guidance to support successful development and commercialization activities in Japan. Key Responsibilities - Regulatory Strategy Leadership - Lead regulatory activities for assigned programs and products in Japan. - Develop and execute regulatory strategies supporting clinical development, registration, and lifecycle management. - Conduct regulatory assessments and provide recommendations for development programs. - Identify regulatory risks and develop mitigation plans. - Provide regulatory guidance to cross-functional teams. - Health Authority Leadership - Lead PMDA consultations and routine regulatory interactions with appropriate management support. - Prepare briefing packages, meeting materials, and responses to health authority inquiries. - Lead or support J-NDA submissions and post-approval activities. - Ensure alignment of Japanese regulatory requirements with global development plans. - Global and Cross-Functional Collaboration - Represent Japan Regulatory Affairs on global project teams. - Collaborate with Clinical Development, Clinical Operations, Medical Affairs, Safety, CMC, Quality, and Medical Writing functions. - Contribute to project decision-making and regulatory planning. - Vendor and CRO Management - Manage regulatory consultants, vendors, and CRO partners supporting Japan activities. - Monitor timelines, deliverables, budgets, and quality of outsourced work. - People Leadership - Mentor junior regulatory colleagues and contribute to team development. - May provide supervisory responsibilities for contractors or junior staff. Qualifications - Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline; advanced degree preferred. - Typically 8+ years of pharmaceutical or biotechnology industry experience, including significant Regulatory Affairs experience. - Experience supporting regulatory strategy for clinical development and registration programs. - Strong knowledge of Japanese pharmaceutical regulations, PMDA processes, and ICH guidelines. - Excellent communication and collaboration skills. Preferred Skills - Oncology drug development experience. - PMDA consultation experience. - Experience supporting NDA/J-NDA submissions. - Experience working on global development programs. - Experience managing vendors or CROs. Leveling Considerations - Independently leads regulatory activities for assigned programs. - Provides strategic regulatory input and manages external partners. - Leads PMDA interactions with appropriate support.