Head of Global Regulatory Affairs and Strategy

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.
• Serve as the primary point of contact for all regulatory interactions; lead the preparation and execution of meetings with global health authorities and Advisory Committees.
• Oversee the end-to-end lifecycle of regulatory findings, from initial IND/CTA submission through BLA/NDA/MAA registration and post-approval maintenance.
• Collaborate with internal AI/ML and Data Science teams to implement technology-driven solutions to streamline submission processes and enhance regulatory strategy and decision-making.
• Act as a key strategic partner to cross-functional stakeholders to ensure development plans, protocols, reports, and manufacturing changes are aligned with regulatory requirements and strategy.
• Monitor evolving global regulatory guidelines and expectations, and translate complex changes into actionable guidance for internal project teams.
• Accountable for global regulatory compliance activities, including GxP compliance, safety reporting, promotional materials, etc.
• Provide regulato

Benefits

Additional Information

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 Match

How well this role fits your profile.

Company Intel

What employees say

Worked at isomorphiclabs? Share your experience