Sr. Director, Regulatory Strategy

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.