Vice President, Regulatory Affairs

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas
12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.

At Editas Medicine, we’re a team of passionate problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and become an Editor!

The Vice President, Regulatory Affairs will lead and build the global regulatory function and strategy for a growing portfolio of in vivo gene editing therapies, serving as the company’s primary regulatory expert and strategic advisor to executive leadership, program teams, the Board, and external partners. Reporting to the Chief Medical Officer, this hands-on leader will oversee all regulatory activities from development candidate selection through clinical development and marketing authorization, including leading interactions with global health authorities, authoring and managing submissions, establishing regulatory processes and systems, and shaping evidence-generation strategies for innovative gene editing products in an evolving regulatory landscape.

This role is suited for an experienced regulatory professional who excels in a fast-paced biotech environment and can seamlessly balance high-level strategy with day-to-day execution in a lean organization.

As the VP, Regulatory Affairs you will:

• Define and execute an integrated global regulatory strategy across the portfolio, aligning regulatory pathways, development plans, resources, risks, and key decision points with corporate priorities.
• Lead regulatory strategy from preclinical development through first-in-human studies, proof of concept, registrational development, and marketing applications, including INDs, CTAs, expedited and special designation requests, and future BLAs/MAAs.
• Provide clear regulatory recommendations, scenario analyses, and risk-mitigation plans to governance bodies and executive leadership; accelerate material issues early and drive timely, evidence-based decisions.
• Serve as the senior regulatory representative and primary day-to-day contact in interactions with FDA, EMA, MHRA, and other health authorities. Personally lead briefing strategy, meeting preparation, rehearsal, negotiation, agency correspondence, responses, commitments, and follow-through.
• Anticipate and address gene editing-specific issues, including editing specificity and off-target assessment, genomic integrity, biodistribution and persistence, immunogenicity, delivery-platform risks, long-term follow-up, durability, and CMC comparability.
• Monitor evolving global policy, guidance, advisory committee activity, and competitive precedent in gene editing, gene therapy, rare disease, and advanced therapeutics, and translate developments into actionable portfolio strategy.
• Partner with Clinical Development, Clinical Operations, Bioanalytics, CMC, Nonclinical, Translational Medicine, Quality, Safety, Legal, and Program Management to ensure development plans and evidence packages are scientifically rigorous, operationally feasible, and regulatory-ready.
• Personally plan, author, coordinate,…