Head of Global Regulatory Affairs and Strategy

Isomorphic Labs•Cambridge, MA

4d•Hybrid

About The Position

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.

Requirements

Education: Bachelor’s in life sciences or related field; advanced scientific or pharmacy degree preferred.
Experience: 15+ years in the pharmaceutical/biotech industry, with extensive experience leading programs from early development (IND/CTA) through successful registration (NDA/BLA/MAA), preferably with oncology and inflammation experience.
Track record: Extensive experience leading regulatory strategy and health authority interactions for clinical-stage assets.
Expertise with the development and preparation of regulatory submissions including briefing books, INDs, and NDA/BLAs (including expedited pathways).
Proven ability to align stakeholders to understand their critical roles and responsibilities in regulatory submission.
A high impact communicator with the ability to influence executive level decisions and represent the company to regulatory authorities.
Knowledge Base: Profound knowledge of global registration processes, ICH guidelines, and direct experience serving as the primary liaison to global health authorities.
Working familiarity with GxP requirements and fundamental components of PV and Quality Management Systems.
Leadership Effectiveness: Demonstrated success in building and mentoring high-impact Regulatory teams in a fast-paced, matrixed environment.
Strong project management, cross-functional coordination, interpersonal skills, conflict resolution, and negotiation skills in multifunctional matrixed and global environments.
Requires some travel.

Nice To Haves

The Builder: Experience scaling a regulatory function and associated compliance departments (Quality/PV) from the ground up in a startup or small-biotech setting.
The Adapter: Ability to pivot seamlessly from high-level global strategy to hands-on tactical execution.
The Innovator: A tech-forward mindset with a passion for leveraging automation, digital tools, or AI to reimagine traditional regulatory workflows.

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 regulatory due diligence and strategic guidance to business development.
Anticipate regulatory risks, propose mitigation strategies, and advise leadership on regulatory pathways, designations, and opportunities to accelerate development.
Lead the selection and management of strategic vendors and consultants.
Host FDA/third party regulatory audits and ensure follow up on findings/observations issued.