Vice President, Regulatory Affairs

Editas Medicine

. Define and execute integrated global regulatory strategy across the portfolio.

Posted 10/8/2026full-timeCambridge • Massachusetts • United StatesLead💰 $345,000 - $372,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in global regulatory strategy and submissions for innovative therapeutics, with a strong focus on gene editing and advanced modalities. Proven ability to lead regulatory operations, manage cross-functional teams, and communicate complex regulatory issues effectively to diverse stakeholders.

Highest-signal resume keywords

Global Regulatory StrategyRegulatory SubmissionsGene Editing ExperienceFDA InteractionsECTD Submission Workflows

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsClinical DevelopmentCMC Regulatory StrategyRegulatory Document AuthoringRisk-Mitigation PlanningRegulatory IntelligenceSubmission Project ManagementRegulatory ComplianceDocument Management SystemsHealth Authority Correspondence

Soft Skills

Executive CommunicationNegotiation SkillsOrganizational LeadershipDecision-MakingCollaboration

Tools & Technologies

Regulatory Information Management SystemsDocument Management SystemsECTD ToolsRegulatory CalendarsCommitments Tracking

Industry Keywords

BiotechnologyPharmaceuticalsGene TherapyCRISPROrphan-Drug DevelopmentInnovative TherapeuticsRegulatory GuidanceClinical TrialsAdvanced TherapiesGxP Compliance

About the role

Key responsibilities & impact

Define and execute integrated global regulatory strategy across the portfolio.
Lead regulatory strategy from preclinical development through first-in-human studies, proof of concept, registrational development, and marketing applications, including INDs, CTAs, designation requests, and future BLAs/MAAs.
Provide regulatory recommendations, scenario analyses, and risk-mitigation plans to governance bodies and executive leadership.
Serve as senior regulatory representative and primary contact with FDA, EMA, MHRA, and other health authorities.
Lead briefing strategy, meeting preparation, agency negotiations, correspondence, responses, commitments, and follow-through.
Address gene editing-specific issues including off-target assessment, genomic integrity, biodistribution, persistence, immunogenicity, delivery-platform risks, long-term follow-up, durability, and CMC comparability.
Monitor global policy, guidance, advisory committee activity, and competitive precedent and translate developments into portfolio strategy.
Partner with Clinical Development, Clinical Operations, Bioanalytics, CMC, Nonclinical, Translational Medicine, Quality, Safety, Legal, and Program Management.
Plan, author, coordinate, compile, review, and drive timely delivery of regulatory submissions and communications.
Own submission-level project management, including content plans, assignments, review cycles, timelines, readiness checks, approvals, publishing handoffs, and filing confirmation.
Draft and edit regulatory documents, integrate cross-functional content, resolve comments, and maintain version and change control.
Manage regulatory operations, agency correspondence, regulatory intelligence, submission and commitment tracking, document archiving, vendor oversight, and regulatory histories.
Lead product-quality regulatory strategy with CMC and Quality teams covering control strategy, potency, specifications, analytical validation, manufacturing changes, comparability, and lifecycle considerations.
Establish and operate the Regulatory Affairs function initially as the sole internal regulatory professional.
Create processes, templates, submission plans, regulatory calendars, trackers, document standards, and governance routines; manage consultants and vendors.
Lead regulatory assessment and strategy for business development, alliances, licensing, and partnered programs.
Maintain inspection-ready regulatory documentation, correspondence, archives, governance records, commitments, and systems; support GxP compliance and inspections.
Represent the company in external forums and communicate complex regulatory issues to scientific, clinical, executive, Board, partner, and investor audiences.

Requirements

What you’ll need

Advanced degree in a scientific, medical, pharmacy, engineering, or related discipline strongly preferred; bachelor’s degree with substantial directly relevant experience considered.
15+ years of progressive experience in biotechnology or pharmaceutical Regulatory Affairs, including experience serving as the senior-most regulatory professional in a small or emerging company and personally executing regulatory work with limited internal infrastructure.
Demonstrated ownership of global regulatory strategy and major submissions for innovative therapeutics, with direct experience authoring and assembling key submission documents, leading FDA interactions, and working with other major health authorities.
Proven experience advancing programs from preclinical development into and through clinical development; late-stage development or marketing application experience is strongly valued.
Deep knowledge of global drug development regulations and guidance, integrating clinical, nonclinical, CMC, safety, quality, and benefit-risk considerations.
Direct regulatory experience with CRISPR or other gene editing therapeutics preferred; relevant experience in gene therapy, RNA therapeutics, mRNA, RNAi, LNP delivery, or other advanced modalities may also be considered.
Experience with in vivo genetic medicines, rare or genetic diseases, orphan-drug development, expedited programs, and innovative or biomarker-driven clinical development.
Experience addressing long-term follow-up, genomic safety, immunogenicity, biodistribution, durability, potency, comparability, and evolving regulatory expectations for advanced therapies.
Ability to work effectively as an individual contributor while managing external regulatory, publishing, medical writing, and consulting resources; prior team-building experience is valued.
Experience in a small or emerging biotechnology company, including building a regulatory function, supporting Board and investor communications, and operating across internal and partnered programs.
Working knowledge of eCTD structure and submission workflows, regulatory information management and document-management systems, submission publishing, regulatory calendars, health-authority correspondence, commitments tracking, and scalable document-governance practices.
Exceptional executive communication, scientific judgment, negotiation, influence, organizational leadership, and decision-making skills.
Strategic, pragmatic, collaborative, highly organized, and willing to move between executive-level strategy and detailed execution.

Benefits

Comp & perks

Blue Cross Blue Shield PPO Medical Plan
Company-funded Health Savings Account
Dental and Vision Insurance
Life and Disability Insurance
Dependent Care Account
Tuition Reimbursement
401(k) plan with company match
Employee Assistance Plan
Wellness Programs
Flexible Paid Time Off policy