New · posted Oct 15
Genetix Biotherapeutics · Biotechnology
Sr. Director, Regulatory Strategy
- Somerville, MA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
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.
This role is based in Somerville, MA and follows a hybrid schedule of three days onsite per week.
What you need
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.
Preferrednice to have
- 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
What you'll do
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.
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.
Pay and benefits
$265,000 – $331,000 a year
Employer providedAdditional 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
Health, life and disability insurance
Employer-matched 401(k)
Lifestyle spending account
Flexible time off and paid holidays
Tuition reimbursement and loan repayment assistance
Paid parental leave
Where you'll work
Somerville, MAHybridOpen in Maps (opens in a new tab)
More jobs in Somerville, MAFrom the posting
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.
To support regular in-office collaboration, only candidates within commuting distance of Somerville will be considered.
Equal opportunity, accessibility and legal noticesGenetix Biotherapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 27% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Massachusetts27 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $265,000 | — | $331,000 |
| Massachusetts (middle half) | $207,500 | $232,500 | $264,500 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Genetix Biotherapeutics's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Genetix Biotherapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 66 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership21
- Regulatory submissions15
- GMP and compliance5
- Documentation and SOPs3
- Investigations and CAPA2
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Genetix Biotherapeutics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 1
- Locations
By discipline
- Quality4 67%
- Regulatory2 33%
By level
- Director3 50%
- Manager3 50%
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Sr. Director, Regulatory Strategy at Genetix Biotherapeutics
Open until filled. $265K–$331K a year, employer provided.