Head of Regulatory Affairs, Gene Editing
hace 2 días
Cambridge
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. The Ideal Transcript: To thrive in this role, 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, with the ability to integrate clinical, nonclinical, CMC, safety, quality, and benefit-risk considerations into a coherent regulatory position., • 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., • Demonstrated ability to work effectively as an individual contributor while managing external regulatory, publishing, medical writing, and consulting resources; prior team-building experience is valued but immediate success in this role depends on hands-on execution rather than delegation., • 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 fluidly between executive-level strategy and detailed execution while balancing speed, scientific innovation, patient safety, regulatory credibility, and long-term value creation. Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a 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, and a flexible Paid Time Off policy. Salary Range: $345,000 – $372,000 Pay Transparency Editas Medicine is committed to transparency and accuracy in our hiring practices. The anticipated salary range for each position is posted within the role. The final salary offer will be determined based on a comprehensive assessment of the candidate's qualifications, including education, training, and relevant experience. Additional factors such as external market conditions, the role's criticality, and internal equity will also be considered. Editas Medicine's compensation philosophy ensures fair and equitable pay practices. Aspire to be an Editor? We invite you to apply and join us at the forefront of innovation and be a key contributor to realizing Editas Medicine's mission of developing transformative medicines for people living with serious diseases. #J-18808-Ljbffr
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