Head of Global Regulatory Affairs and Strategy
Isomorphic Labs, Cambridge, MA, United States
Overview
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, enabled by machine learning, with diseases curtailed or cured through better and faster drug discovery. Join an interdisciplinary team driving groundbreaking innovation and contribute to an inspiring, collaborative culture. The world we want tomorrow starts with the culture at Iso and with you. About Iso
IsoLabs was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Our interdisciplinary team has built powerful predictive and generative AI models that accelerate scientific discovery at digital speed. Our name reflects the symmetry between biology and information science. We model complex biological phenomena with AI to design novel molecules, anticipate drug performance, and develop innovative medicines to treat and cure diseases. We have a world-leading drug design engine that works across multiple therapeutic areas and drug modalities, continually innovating to advance rational drug design. Every day, with each breakthrough, we move closer to the promise of digital biology and solving all disease with AI. Your impact
The 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 regulatory initiatives. Reporting to the Chief Medical Officer, this role will be the founding architect of the 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 to build a global regulatory foundation that accelerates products from early development through registration and to 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 speed and accuracy, ensuring programs are positioned for rapid global approval. The role will partner with cross-functional teams to prepare for regulatory interactions and drive the strategic development of the portfolio. Responsibilities
Define and continuously optimize global regulatory strategies for development programs. Formulate overall regulatory strategies, optimize filing pathways, mitigate registration risks, and ensure filing milestones are achieved. Establish scalable regulatory capabilities, processes, systems, and standards for a lean startup, including eCTD document management and submission planning. Architect and implement a phase-appropriate QMS to ensure GxP compliance and audit readiness. Establish the global PV infrastructure, including safety reporting workflows and executive oversight of benefit-risk for clinical assets. Define the Medical Writing strategy for consistent scientific narrative across regulatory dossiers. Serve as the primary contact for regulatory interactions; lead meetings with global health authorities and Advisory Committees. Oversee the end-to-end lifecycle of regulatory findings from 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 submissions and enhance regulatory decision-making. Partner with cross-functional stakeholders to ensure development plans, protocols, reports, and manufacturing changes align with regulatory requirements and strategy. Monitor evolving global regulatory guidelines and translate changes into actionable guidance for project teams. Ensure global regulatory compliance activities, including GxP, safety reporting, and promotional materials. Provide regulatory due diligence and strategic guidance to business development. Anticipate regulatory risks, propose mitigation strategies, and advise leadership on pathways, designations, and opportunities to accelerate development. Lead the selection and management of strategic vendors and consultants. Host FDA/third-party regulatory audits and address findings/observations. Requires some travel. Qualifications
Essential Education: Bachelor’s in life sciences or related field; advanced scientific or pharmacy degree preferred. Experience: 15+ years in pharma/biotech with leadership of programs from IND/CTA through NDA/BLA/MAA, preferably with oncology or inflammation experience. Track record: Leadership of regulatory strategy and health authority interactions for clinical-stage assets; experience with regulatory submissions including briefing books, INDs, NDA/BLAs and expedited pathways; ability to align stakeholders and influence executive decisions. Knowledge: Global registration processes, ICH guidelines, GxP familiarity, and PV/Quality Management System components. Leadership: Experience building and mentoring Regulatory teams in fast-paced, global environments; strong project management and cross-functional coordination. Preferred The Builder: Experience scaling regulatory functions and compliance (Quality/PV) in startup or small-biotech settings. The Adapter: Ability to move from high-level strategy to hands-on execution. The Innovator: Tech-forward mindset with automation, digital tools, or AI to reimagine regulatory workflows. Closing date
Closing date: 7 April Culture and values
We are guided by our shared values. It’s not about finding people who think and act the same way; these values guide our work and strengthen it. Thoughtful
– Curious, creative, and caring; good people doing good, rigorous science daily. Brave
– Fearless, with initiative and integrity; the scale of the challenge demands nothing less. Determined
– The pursuit of our goal with urgency and agility because disease won’t wait. Together
– Collaboration across fields and catalytic relationships to create real impact for people everywhere. Creating An Extraordinary Company
– We value diverse skills and backgrounds and foster an environment where everyone can thrive; we are committed to equal employment opportunities. If you require accommodations due to disability or additional needs, please let us know. Hybrid working We follow a hybrid model and expect to come into the office 3 days a week (Tuesday, Wednesday, and one other day based on team). If you have needs that prevent this, we can discuss during screening. Please note that when you submit an application, your data will be processed in line with our privacy policy. Click to view other open roles at Isomorphic Labs
#J-18808-Ljbffr
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, enabled by machine learning, with diseases curtailed or cured through better and faster drug discovery. Join an interdisciplinary team driving groundbreaking innovation and contribute to an inspiring, collaborative culture. The world we want tomorrow starts with the culture at Iso and with you. About Iso
IsoLabs was launched in 2021 to advance human health by building on and beyond the Nobel-winning AlphaFold system. Our interdisciplinary team has built powerful predictive and generative AI models that accelerate scientific discovery at digital speed. Our name reflects the symmetry between biology and information science. We model complex biological phenomena with AI to design novel molecules, anticipate drug performance, and develop innovative medicines to treat and cure diseases. We have a world-leading drug design engine that works across multiple therapeutic areas and drug modalities, continually innovating to advance rational drug design. Every day, with each breakthrough, we move closer to the promise of digital biology and solving all disease with AI. Your impact
The 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 regulatory initiatives. Reporting to the Chief Medical Officer, this role will be the founding architect of the 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 to build a global regulatory foundation that accelerates products from early development through registration and to 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 speed and accuracy, ensuring programs are positioned for rapid global approval. The role will partner with cross-functional teams to prepare for regulatory interactions and drive the strategic development of the portfolio. Responsibilities
Define and continuously optimize global regulatory strategies for development programs. Formulate overall regulatory strategies, optimize filing pathways, mitigate registration risks, and ensure filing milestones are achieved. Establish scalable regulatory capabilities, processes, systems, and standards for a lean startup, including eCTD document management and submission planning. Architect and implement a phase-appropriate QMS to ensure GxP compliance and audit readiness. Establish the global PV infrastructure, including safety reporting workflows and executive oversight of benefit-risk for clinical assets. Define the Medical Writing strategy for consistent scientific narrative across regulatory dossiers. Serve as the primary contact for regulatory interactions; lead meetings with global health authorities and Advisory Committees. Oversee the end-to-end lifecycle of regulatory findings from 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 submissions and enhance regulatory decision-making. Partner with cross-functional stakeholders to ensure development plans, protocols, reports, and manufacturing changes align with regulatory requirements and strategy. Monitor evolving global regulatory guidelines and translate changes into actionable guidance for project teams. Ensure global regulatory compliance activities, including GxP, safety reporting, and promotional materials. Provide regulatory due diligence and strategic guidance to business development. Anticipate regulatory risks, propose mitigation strategies, and advise leadership on pathways, designations, and opportunities to accelerate development. Lead the selection and management of strategic vendors and consultants. Host FDA/third-party regulatory audits and address findings/observations. Requires some travel. Qualifications
Essential Education: Bachelor’s in life sciences or related field; advanced scientific or pharmacy degree preferred. Experience: 15+ years in pharma/biotech with leadership of programs from IND/CTA through NDA/BLA/MAA, preferably with oncology or inflammation experience. Track record: Leadership of regulatory strategy and health authority interactions for clinical-stage assets; experience with regulatory submissions including briefing books, INDs, NDA/BLAs and expedited pathways; ability to align stakeholders and influence executive decisions. Knowledge: Global registration processes, ICH guidelines, GxP familiarity, and PV/Quality Management System components. Leadership: Experience building and mentoring Regulatory teams in fast-paced, global environments; strong project management and cross-functional coordination. Preferred The Builder: Experience scaling regulatory functions and compliance (Quality/PV) in startup or small-biotech settings. The Adapter: Ability to move from high-level strategy to hands-on execution. The Innovator: Tech-forward mindset with automation, digital tools, or AI to reimagine regulatory workflows. Closing date
Closing date: 7 April Culture and values
We are guided by our shared values. It’s not about finding people who think and act the same way; these values guide our work and strengthen it. Thoughtful
– Curious, creative, and caring; good people doing good, rigorous science daily. Brave
– Fearless, with initiative and integrity; the scale of the challenge demands nothing less. Determined
– The pursuit of our goal with urgency and agility because disease won’t wait. Together
– Collaboration across fields and catalytic relationships to create real impact for people everywhere. Creating An Extraordinary Company
– We value diverse skills and backgrounds and foster an environment where everyone can thrive; we are committed to equal employment opportunities. If you require accommodations due to disability or additional needs, please let us know. Hybrid working We follow a hybrid model and expect to come into the office 3 days a week (Tuesday, Wednesday, and one other day based on team). If you have needs that prevent this, we can discuss during screening. Please note that when you submit an application, your data will be processed in line with our privacy policy. Click to view other open roles at Isomorphic Labs
#J-18808-Ljbffr