Head of Global Regulatory Affairs and Strategy

Isomorphic Labs is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to solve all disease. The future is coming. A future enabled and enriched by the incredible power of machine learning. A future in which diseases are curtailed or cured starting with better and faster drug discovery. Come and be part of an interdisciplinary team driving groundbreaking innovation and play a meaningful role in contributing towards us achieving our ambitious goals, while being a part of an inspiring and collaborative culture. The world we want tomorrow is the one we’re building today. It starts with the culture at this company. It starts with you. About Iso Isomorphic Labs (IsoLabs) was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Since then, our interdisciplinary team of drug discovery experts and machine learning specialists has built powerful new predictive and generative AI models that accelerate scientific discovery at digital speed. Our name comes from the belief that there is an underlying symmetry between biology and information science. By harnessing AI’s powerful capabilities, we can use it to model complex biological phenomena to help design novel molecules, anticipate how drugs will perform and develop innovative medicines to treat and cure some of the world’s most devastating diseases. We have built a world-leading drug design engine comprising AI models that are capable of working across multiple therapeutic areas and drug modalities. We are continually innovating on model architecture and developing cutting-edge capabilities to advance rational drug design. Every day, and with each new breakthrough, we’re getting closer to the promise of digital biology, and achieving our ambitious mission to one day solve all disease with the help of AI. Your impact The experienced and visionary Head of Global Regulatory Affairs and Strategy will lead regulatory strategy for all assets from IND to POC to registration and leverage AI to advance initiatives to transform regulatory pathways. Reporting to the Chief Medical Officer, this role will be the founding architect of our Regulatory function, responsible for building the team, systems, and vendor ecosystem required to transition into a clinical-stage organization. This is a high impact leadership role for a strategist who will build a global regulatory foundation designed to accelerate products from early development through successful registration. This senior leader will also design and implement the company’s foundational Quality, Pharmacovigilance (PV) and Medical Writing frameworks. By leveraging AI and emerging technologies, this role will streamline regulatory workflows with unprecedented speed and accuracy, ensuring our programs are optimally positioned for rapid global approval. This role will partner closely with various cross-functional teams to prepare for high-stakes regulatory interactions and drive the strategic development of our portfolio forward. Responsibilities Define and continuously optimize global regulatory strategies for development programs. Formulate overall regulatory strategies, optimize the filing pathways, mitigate registration risks, and ensure the achievement of filing milestones. Establish scalable regulatory capabilities, processes, systems, and standards appropriate for a lean startup environment, including Electronic Common Technical Document (eCTD) document management and submission planning. Architect and implement a phase-appropriate Quality Management System (QMS) to ensure GxP compliance and internal and external audit readiness. Establish the company’s global PV infrastructure, including safety reporting workflows and executive oversight of the benefit-risk profile for clinical assets. Define the Medical Writing strategy to ensure scientific narrative consistency across all regulatory dossiers. S ... (truncated, view full listing at source)