Director, Regulatory & Compliance

Job Description

• Remote, full-time Director-level regulatory and compliance leadership role at Absci, a clinical-stage biotechnology company using generative AI for drug discovery; level may be Director or Senior Director based on experience and scope.
• Build and own the company's ethics, compliance, regulatory strategy, government affairs, privacy, and data governance functions across the product development and commercial lifecycle.
• Lead FDA submissions, regulatory agency interactions and inspections, international regulatory strategy involving EMA and ICH, internal investigations, audits, corrective actions, and remediation.
• Develop GDPR-ready governance covering DPIAs, ROPAs, data subject rights, privacy-by-design, vendor DPAs, sub-processors, and breach response meeting the GDPR 72-hour notification window.
• Requires 14+ years spanning regulatory affairs and/or compliance in biotech or pharma, hands-on FDA experience, a bachelor's degree in a scientific or legal discipline, and U.S. work authorization; salary is $195K–$240K/year.