At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a 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.
Why Choose Editas?
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!
Decoding The Role:
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; escalate 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, compile, review, and drive the on-time delivery of regulatory submissions and communications, including INDs/CTAs, amendments, annual reports, safety reports, meeting requests and briefing packages, designation requests, responses to information requests, and other agency correspondence.
- Own submission-level project management: define content plans, author assignments, review cycles, dependencies, timelines, readiness checks, approvals, publishing handoffs, and filing confirmation.
- Draft and edit core regulatory documents and integrate cross-functional source content into a clear, consistent company position; identify content gaps, resolve comments, and maintain version and change control.
- Manage routine regulatory operations, including agency correspondence, regulatory intelligence, submission and commitment tracking, document archiving, vendor oversight, and maintenance of the regulatory history for each program.
- Lead product-quality regulatory strategy and execution, working directly with CMC and Quality colleagues to develop submission content addressing control strategy, potency, specifications, analytical validation, manufacturing changes, comparability, and lifecycle considerations for gene editing components and delivery systems.
- Establish and operate a fit-for-purpose Regulatory Affairs function as the sole internal regulatory professional initially. Create practical processes, templates, submission plans, regulatory calendars, correspondence and commitment trackers, document standards, and governance routines; manage consultants and vendors selectively to extend capacity while retaining direct ownership of the work.
- Lead regulatory assessment and strategy for business development, alliances, licensing, and partnered programs, including diligence, governance, and alignment of responsibilities and regulatory positions.
- Maintain inspection-ready regulatory documentation, health-authority correspondence, submission archives, governance records, commitments, and regulatory systems. Partner with Quality to develop appropriate procedures, support GxP compliance, and prepare for health authority inspections.
- Represent the company in appropriate external forums and communicate complex regulatory issues with precision to scientific, clinical, executive, Board, partner, and investor audiences.