Isomorphic Labs
Head of Global Regulatory Affairs and Strategy
Cambridge, MA · Exec
Sponsorship not specifiedDetected 28 days ago
Machine LearningData ScienceLLMsComplianceProject ManagementNegotiationAuditingFDA RegulatoryPharmacovigilanceLeadershipCollaborationMentoringInternal AuditGxPRegulatory Affairs
About the role
- 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.
- 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.
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.
- 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.
- 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.
- 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 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.
- Lead the selection and management of strategic vendors and consultants.
Requirements
- Ability to pivot seamlessly from high-level global strategy to hands-on tactical execution.
Nice to have
- Bachelor's in life sciences or related field
- advanced scientific or pharmacy degree preferred.
- Strong project management, cross-functional coordination, interpersonal skills, conflict resolution, and negotiation skills in multifunctional matrixed and global environments.
Skills
- A tech-forward mindset with a passion for leveraging automation, digital tools, or AI to reimagine traditional regulatory workflows.
Benefits
- 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.
- This senior leader will also design and implement the company's foundational Quality, Pharmacovigilance (PV) and Medical Writing frameworks.
Visa & Work Authorization
- equal employment opportunities regardless of sex, race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, gender identity, pre
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