Teams at NewAmsterdam Pharma Corporation

Own enterprise data governance, metadata, lineage, data quality, master data, GxP readiness, cloud data-layer standards, commercial data controls, partner data exchanges, and AI data governance. Lead federated stewardship, executive scorecards, architecture reviews, access models, vendor data governance, and regulatory readiness across clinical, commercial, and corporate data. Partner with Security, Legal, Privacy, Compliance, and QA while building accountable business ownership and trustworthy, rapidly accessible data.

Leads global regulatory strategy, submissions, compliance, and lifecycle management for clinical-stage pharmaceutical programs. Oversees IND, NDA, CTA, and MAA filings; advises cross-functional teams on clinical trial design and labeling; ensures compliance with FDA, EMA, and ICH requirements; and manages regulatory interactions, consultants, CROs, timelines, budgets, and vendor deliverables.

Supports global regulatory strategies, submissions, compliance, labeling, and lifecycle management for clinical-stage therapies. Prepares and reviews INDs, NDAs, CTAs, and MAAs; advises cross-functional teams on FDA, EMA, and ICH requirements; collaborates with clinical, CMC, and quality teams; and manages external consultants and CRO vendors to ensure compliant, timely, and high-quality deliverables.