NewAmsterdam Pharma Corporation

Vice President

• Lead the continued development, implementation, operation, and oversight of the Company’s compliance program
• Serve as a strategic partner to Commercial leadership and engage early in commercial strategy development
• Identify and assess compliance considerations and develop practical, compliant approaches to business objectives
• Report periodically to senior leadership and the Board of Directors or its committees on the compliance program and key risks
• Champion a culture in which compliance is integrated into business decision-making
• Build strong relationships across the organization and serve as a trusted advisor
• Develop, implement, and review compliance policies, procedures, standards, and business processes
• Develop and oversee compliance education and training
• Establish and execute risk-based monitoring and auditing plans
• Lead or facilitate investigations of suspected non-compliance and oversee corrective and preventive actions
• Oversee federal and state transparency reporting and healthcare compliance requirements
• Serve as the Company’s Privacy Officer and oversee its privacy compliance framework
• Identify and assess emerging compliance risks and translate complex requirements into practical guidance

Senior Vice President, Head of Compliance

• Advise on payer and PBM engagement, formulary access, contracting, pricing, reimbursement, rebate arrangements, government program considerations, and other access initiatives
• Counsel on channel strategy, wholesaler and specialty pharmacy relationships, distribution arrangements, service-fee structures, data arrangements, inventory/product-flow issues, and related contracts
• Advise on benefits verification, prior authorization support, copay assistance, patient assistance programs, adherence and education services, privacy, fraud and abuse, and hub/vendor relationships
• Serve as a trusted legal advisor to the commercial organization before and after launch
• Translate legal and regulatory requirements into clear, practical, business-oriented advice
• Partner with business leaders to understand objectives, anticipate issues, assess risk, and develop compliant paths forward
• Support launch strategies, capabilities, policies, business processes, and cross-functional decision-making
• Take ownership of matters from issue identification through resolution
• Draft, review, and negotiate agreements supporting launch and commercialization
• Develop scalable templates, playbooks, processes, policies, training, and commercial legal capabilities
• Provide or coordinate legal guidance on HCP engagements, sales, marketing, sponsorships, congress activities, exhibits, business rationale, FMV, contracting, and related compliance considerations
• Support review of promotional, disease awareness, payer, patient, medical, scientific education, and other external-facing materials
• Advise on FDA promotional requirements and related standards

Vice President, Commercial Counsel

• Develop US and global regulatory strategies aligned with business objectives
• Provide guidance, direction, and leadership on regulatory strategies to the development team and senior management
• Make strategic contributions to clinical development plans
• Lead the regulatory team in providing expert advice to development teams and operationalizing key regulatory activities
• Identify talent growth opportunities and forecast team capability needs as the pipeline evolves
• Prepare meeting requests and briefing documents, coordinate and prepare teams for meetings, and serve as the primary liaison with regulatory authorities
• Maintain working knowledge of US and EU laws, regulations, guidelines, and the global regulatory environment
• Identify and collaborate with regulatory experts and consultants
• Coordinate and prepare responses to requests for information from regulatory authorities
• Represent Regulatory Affairs on cross-functional development teams
• Establish, update, and implement regulatory policies, standards, and procedures
• Lead global regulatory strategy across late-stage development, launch readiness, product registration, and post-approval lifecycle management
• Partner with Commercial, Medical Affairs, Legal/Compliance, Quality, Pharmacovigilance, Supply Chain, and Market Access on launch readiness, compliant communications, labeling, and lifecycle planning
• Ensure regulatory operations comply with FDA, EU, ICH, EMA, and industry standards
• Manage regulatory aspects of products and projects, including timelines and deliverables
• Guide electronic regulatory submissions and support development teams in their preparation
• Author, review, and edit informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports
• Work with the selected EU Designated Person to ensure Good Distribution Practices of API
• Report to the Chief Medical Officer

Senior Vice President, Global Regulatory Affairs

Risk

• Own enterprise data governance strategy, policy, and the federated stewardship model
• Co-chair the Data Governance Council with Quality Assurance
• Own metadata, business glossary, and end-to-end lineage across clinical, commercial, and corporate data
• Lead the data quality program and report domain scorecards to the executive team
• Own master data end to end across clinical, commercial, and regulatory domains
• Define GxP readiness for the data layer, including validated-zone criteria and boundaries
• Govern the data management practice and platform data layer
• Establish modeling standards and SLAs for certified data products
• Govern the CRO and vendor data supply chain
• Participate hands-on in architecture reviews, access model design, and data quality investigations
• Lead the commercial data foundation ahead of the US launch
• Govern controls behind transparency reporting and the commercial–medical firewall
• Oversee partner data interfaces for net sales, channel, and safety data exchange
• Establish data governance for AI, including provenance, model input controls, and EU AI Act readiness
• Translate Security, Legal, Privacy, Compliance, and QA obligations into implementable data controls

Senior Vice President, Head of Compliance

Vice President, Commercial Counsel

Senior Vice President, Global Regulatory Affairs

Director, Enterprise Data Management – Governance Lead