Director, Regulatory & Compliance

Role: Lead regulatory and compliance functions at Absci, focusing on building and maintaining ethics, regulatory strategy, and data privacy programs for a biotech firm leveraging AI in drug development. Responsibilities: develop and execute regulatory strategies aligned with FDA, EMA, ICH; oversee the ethics and compliance program, including policies, training, monitoring, and audits; serve as primary liaison for regulatory agency interactions and inspections; monitor evolving global regulatory landscapes, including AI/ML guidance and data privacy laws; lead internal investigations, manage corrective actions, and establish GDPR-ready data governance frameworks; collaborate cross-functionally with Legal, Quality, Engineering, and Product teams; report to CLO and stakeholders on compliance status. Requirements: 14+ years in biotech, pharma, or related regulated industry with hands-on FDA submission experience; demonstrated ability to build or significantly scale compliance programs; strong communication skills; Bachelor's degree in scientific or legal field; advanced degree preferred. Nice to Have: experience in clinical-stage or early-commercial biotech, understanding of AI/ML regulatory considerations, government affairs experience. High-Value: biotech/pharma industry, regulatory affairs, compliance programs, FDA interactions, data privacy (GDPR), AI/ML in drug discovery, cross-functional collaboration, senior leadership reporting, US-based with potential international regulatory knowledge.