--- title: 'Sr. Director, Regulatory Strategy at Genetix Biotherapeutics' canonical: 'https://feeny.ai/job/sr-director-regulatory-strategy-genetix-biotherapeutics-somerville-fpj4qjceza7s' type: 'job' last_seen: '2026-09-07' --- # Sr. Director, Regulatory Strategy at Genetix Biotherapeutics - **Company:** Genetix Biotherapeutics - **Location:** Somerville, MA - **Compensation:** $265k–$331k - **Posted:** 2026-09-04 - **Last confirmed live:** 2026-09-07 - **Apply:** https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/8180028 ## Job description ## About Genetix Biotherapeutics At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. This role is based in Somerville, MA and follows a hybrid schedule of three days onsite per week. To support regular in-office collaboration, only candidates within commuting distance of Somerville will be considered. Position Summary Genetix is seeking an experienced and strategic Senior Director of Regulatory Strategy to lead regulatory strategy and health authority interactions across our portfolio of transformative gene therapies. This is a hands-on leadership role for a regulatory strategist who can move seamlessly from defining the strategy to executing it. The Senior Director will serve as a primary regulatory expert supporting interactions with the U.S. Food and Drug Administration (FDA) and will play a critical role in shaping global regulatory strategy for approved products. The successful candidate will be expected to define the regulatory framework and strategic positioning, drive cross functional and executive alignment, and personally execute critical regulatory deliverables. The successful candidate must have strong written and oral communication skills and have experience writing regulatory briefing documents, leading meetings with health authorities, and partnering with regulatory agencies to advance complex therapies (experience with cell or gene therapies is preferred.) Working with a lean team of SMEs, the candidate will lead preparation of meetings and author meeting materials. The candidate will roll up their sleeves to ensure high-quality documents. An additional key responsibility will be working to develop and execute the regulatory roadmap to support future European Union submissions for existing products, including regulatory gap assessments, EU engagement strategy, pediatric planning, and preparation for Marketing Authorization Applications (MAAs). Experience with ICH country regulations is preferred. The successful candidate will partner closely with Medical Affairs, Clinical Development, CMC, Quality, Commercial, and Executive Leadership to accelerate patient access to life-changing therapies while ensuring regulatory excellence and compliance. ## Key Responsibilities FDA Regulatory Leadership - Serve as a senior regulatory strategist and lead regulatory science activities supporting Genetix products. - Develop and execute regulatory strategies for post-approval lifecycle management activities, label expansions, and new indications. - Lead cross-functional preparation for FDA interactions, including Type B, Type C, Type D, and pre-submission meetings. - Develop briefing books, meeting packages, response documents, and regulatory correspondence in collaboration with subject matter experts. - Advise cross-functional teams on FDA regulatory requirements, risks, precedents, and evolving policy. - Conduct regulatory assessments supporting product enhancements, comparability strategies, manufacturing changes, and long-term follow-up programs in collaboration with the CMC Reg team. - Represent Regulatory Science on governance committees and in executive leadership discussions. EU Regulatory Strategy & Execution - Lead the strategic initiative to obtain European Union approvals for existing products. - Conduct comprehensive regulatory gap analyses for clinical, nonclinical, and CMC data packages. - Develop the EU regulatory roadmap, including scientific advice strategy, Pediatric Investigation Plans (PIPs), and Marketing Authorization Application readiness. - Build and manage relationships with EMA and national competent authorities. - Coordinate regulatory consultants and subject-matter experts supporting European submissions. - Develop submission timelines, resource requirements, risk assessments, and mitigation plans. - Provide executive recommendations regarding optimal filing pathways and market-entry strategies. Global Regulatory Strategy - Manage the Regulatory Strategy team - Support the regulatory strategy activities of our GCC partner company and oversee geographic expansion activities - Monitor evolving global regulations and guidance relevant to gene therapy, cell therapy, and rare disease products. - Interpret emerging regulatory expectations and translate them into actionable development and commercialization strategies. - Lead regulatory intelligence activities and communicate implications to leadership. - Contribute to regulatory strategy for potential future pipeline assets and business development opportunities. Cross-Functional Leadership - Partner closely with: - Clinical Development - Medical Affairs - Technical Operations and CMC - Quality Assurance - Pharmacovigilance - Commercial and Market Access - Legal and Compliance - Serve as a trusted advisor to executive leadership on regulatory opportunities and risks. - Lead cross-functional teams through complex regulatory initiatives and major submissions. - Mentor and develop regulatory professionals and matrix teams. ## Qualifications Required - Advanced degree in life sciences, pharmacy, medicine, regulatory science, or a related field (PhD, PharmD, MD, or equivalent preferred). - Minimum 10 years of biotechnology or pharmaceutical industry experience. - Minimum 6 years of progressive regulatory affairs/regulatory strategy experience. - Demonstrated leadership of successful FDA interactions and major US regulatory submissions. - Experience with major ex-US health authorities, e.g., ICH countries - Experience with biologics, cell therapies, gene therapies, or other advanced therapies. - Strong understanding of FDA regulations, guidance documents, and regulatory procedures. - Excellent written, verbal, and presentation skills. - Proven ability to influence senior leaders and drive decisions across functions. ## Preferred - Direct experience with gene therapy products. - Experience supporting BLA approvals and post-marketing lifecycle management. - Prior experience engaging with EMA and European regulatory agencies. - Experience developing Pediatric Investigation Plans (PIPs). - Regulatory experience in hematology, rare diseases, or genetic disorders. - Experience leading global regulatory teams and external regulatory consultants. - Experience working with lean resources in a nimble environment Critical Success Factors The ideal candidate will: - Be viewed as a credible FDA and EMA strategist. - Balance scientific rigor with business pragmatism. - Thrive in a fast-paced biotech environment. - Hands-on mindset, working with a lean internal team of SMEs. - Demonstrate exceptional judgment when navigating regulatory uncertainty. - Build strong partnerships across Regulatory, Medical, Clinical, Technical Operations, and Executive Leadership. - Maintain a relentless focus on accelerating patient access to transformative gene therapies. First-Year Objectives - Lead FDA engagement strategy supporting ongoing Lyfgenia and Zynteglo lifecycle-management initiatives. - Establish a comprehensive EMA readiness assessment for both products. - Deliver an executable EU regulatory roadmap, including PIP and scientific advice strategies. - Build regulatory submission plans targeting future EU marketing authorizations. - Strengthen regulatory intelligence capabilities across the organization. - Serve as a strategic regulatory partner to the Executive Leadership Team. Additional Information The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law. Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more. Pay Transparency $265,000—$331,000 USD Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics. ## About Genetix Biotherapeutics ## Company Overview - **One-liner**: Genetix Biotherapeutics (formerly bluebird bio) is a commercial-stage biotechnology company dedicated to developing and delivering one-time, curative genetic therapies for patients with severe rare genetic diseases. - **Entity Type**: Private (taken private in June 2025 after a sale to new ownership) - **Headquarters**: Somerville, Massachusetts, USA (with a presence in the Netherlands) - **Founded**: 1992 (founded as Genetix Pharmaceuticals; rebranded to bluebird bio in 2010; rebranded back to Genetix Biotherapeutics in September 2025) - **Founders**: Not publicly disclosed; the company was originally founded as Genetix Pharmaceuticals in 1992. ## Core Business - **Primary Industries**: Biotechnology, Gene Therapy, Rare Disease Therapeutics - **Target Customers**: B2B (healthcare providers, qualified treatment centers, payers/insurers) and B2C (patients with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy) - **Mission**: "To transform lives through curative therapies for patients with rare, genetic diseases." ## Products & Services - **LYFGENIA™ (lovotibeglogene autotemcel / lovo-cel)**: An FDA-approved, one-time gene therapy for patients 12 years and older with sickle cell disease. It works by adding functional copies of a modified β-globin gene into the patient's own blood stem cells. - **ZYNTEGLO™ (betibeglogene autotemcel)**: An FDA-approved, one-time gene therapy for patients with β-thalassemia who require regular blood transfusions. It adds functional copies of a modified β-globin gene into the patient's own blood stem cells. - **SKYSONA™ (elivaldogene autotemcel)**: An FDA-approved, one-time gene therapy for boys with cerebral adrenoleukodystrophy (CALD), a rare, progressive genetic brain disease. It adds a functional copy of the ABCD1 gene into the patient's own blood stem cells. - **Patient Support Program**: Personalized assistance for patients and families navigating the treatment journey, including insurance questions, treatment center coordination, and one-on-one support. ## Market Standing - **Valuation/Market Cap**: Not publicly disclosed (privately held after take-private transaction in June 2025) - **Key Metrics**: - **Annual Revenue**: Not publicly disclosed (but the company reported strong revenue growth in 2025 and achieved its **first ever profitable quarter** in that year) - **Total Funding**: Not publicly disclosed (new investors provided "significant capital" to support operational objectives following the take-private transaction) - **Notable Investors/Partners**: New ownership group (undisclosed); manufacturing partners include **Minaris**, **Lonza**, and **MilliporeSigma** (the U.S. and Canada business of Merck KGaA, Darmstadt, Germany) - **Growth Signals**: - **2025 commercial performance**: >100 patients treated in the U.S.; >150 patients completed their first cell collection cycle; 70 active Qualified Treatment Centers (QTCs) — the largest network for hemoglobinopathy gene therapies nationwide - **2026 outlook**: Doubling manufacturing capacity by mid-2026; targeting first full year of profitability; expanding LYFGENIA label to pediatric patients <12 years of age; advancing cryopreserved apheresis to improve the treatment experience ## Competitive Advantages - **First-mover & market leader**: The only company with FDA approval for three gene therapies, and the market leader in the U.S. for hemoglobinopathy gene therapies - **Proven commercial model**: >100 patients treated in a single year demonstrates real-world commercial execution and manufacturing scale - **Decades of scientific innovation**: Over 30 years of R&D in genetic therapy, with extensive clinical data from hundreds of treated patients (including 15-year long-term follow-up studies) - **Strong access**: LYFGENIA and ZYNTEGLO have meaningful access for >90% of eligible patients with commercial or Medicaid coverage - **One-time curative approach**: Therapies are designed to treat the underlying cause of disease, offering durable, potentially life-long benefits from a single administration ## Strategic Focus - **Commercial execution & patient access**: Expanding the Qualified Treatment Center network and making the treatment journey simpler for patients and providers - **Manufacturing scale-up**: Doubling manufacturing capacity in 2026 through partnerships with CDMOs to meet growing patient demand - **Process optimization**: Implementing cryopreserved apheresis to improve the patient and provider experience - **Label expansion**: Advancing the HGB-210 Phase 3 study to bring LYFGENIA to pediatric sickle cell patients under 12 years of age - **Full-year profitability**: Targeting the company's first full year of profitability in 2026 ## Why Work Here - **Mission-driven culture**: "United by purpose" — the company is laser-focused on transforming the lives of patients with rare, genetic diseases through curative therapies - **Strong momentum**: Recently achieved first-ever profitable quarter, with rapid commercial growth and a clear plan for expansion in 2026 - **Remote/hybrid policy**: Roles are listed as both on-site (Somerville, MA) and remote (e.g., Account Manager, Gene Therapy) — flexible arrangements appear available depending on the role - **Active hiring**: 23 job postings as of the search date, spanning Commercial, Quality Assurance, Technical Operations, Medical, and Regulatory functions - **Experienced leadership**: Led by CEO David Meek (ex-Mirati Therapeutics, Ipsen) with a seasoned executive team of industry veterans, signaling strong strategic direction - **Notable perks/culture**: High-impact work at the intersection of cutting-edge science and commercial execution; opportunity to join a company in the middle of a dramatic turnaround and growth phase; patient-centric focus with a dedicated support program ## Sources 1. [genetixbiotx.com - Company website](https://www.genetixbiotx.com/) 2. [job-boards.greenhouse.io - Careers page](http://job-boards.greenhouse.io/genetixbiotherapeutics) 3. [linkedin.com - LinkedIn company page](https://www.linkedin.com/company/genetix-biotherapeutics) 4. [genetixbiotx.com - Press release: Rebrand from bluebird bio](https://www.genetixbiotx.com/press-release-2025-09-18.html) 5. [genetixbiotx.com - Press release: 2025 commercial results & 2026 priorities](https://www.genetixbiotx.com/press-release-2026-03-02.html) ## Other roles at Genetix Biotherapeutics - [Sr. Manager - IT Commercial and Medical Systems](https://feeny.ai/job/sr-manager-it-commercial-and-medical-systems-genetix-biotherapeutics-somerville-drs30kf4perv) — Somerville, MA - [Manager, End User Services & Lab Support](https://feeny.ai/job/manager-end-user-services-lab-support-genetix-biotherapeutics-somerville-q2ah951d4k1c) — Somerville, MA - [Director, Regulatory Advertising and Promotion](https://feeny.ai/job/director-regulatory-advertising-and-promotion-genetix-biotherapeutics-somerville-4ykm3383hgsq) — Somerville, MA - [Regional Medical Director, Gene Therapy](https://feeny.ai/job/regional-medical-director-gene-therapy-genetix-biotherapeutics-remote-wz9vc7s3xy0n) - [Paralegal and Legal & Compliance Operations Manager](https://feeny.ai/job/paralegal-and-legal-compliance-operations-manager-genetix-biotherapeutics-m768zfn33tct) — Somerville, MA - [Associate Manager, Quality Assurance Operations](https://feeny.ai/job/associate-manager-quality-assurance-operations-genetix-biotherapeutics-8m008cez8h16) — Somerville, MA - [Sr. Manager, Quality Assurance for Quality Control](https://feeny.ai/job/sr-manager-quality-assurance-for-quality-control-genetix-biotherapeutics-j6a4xrp93mf0) — Somerville, MA - [Director, Value Communications](https://feeny.ai/job/director-value-communications-genetix-biotherapeutics-somerville-yxp6wwwsrt3f) — Somerville, MA - [Account Manager, Gene Therapy - Pacific Northwest](https://feeny.ai/job/account-manager-gene-therapy-pacific-northwest-genetix-biotherapeutics-seattle-cdgars1xqtra) — Seattle, WA - [Director of Scientific Communications & Evidence Generation](https://feeny.ai/job/director-of-scientific-communications-evidence-generation-genetix-ddek20fjzkgt) — Somerville, MA