Sr. Director, Regulatory Strategy

About the role

Genetix Biotherapeutics is seeking a senior leader to shape and execute regulatory strategy for its portfolio of transformative gene therapies. Based in Somerville, MA, this hybrid role blends strategic planning with hands‑on execution, driving interactions with the FDA and European regulators.

Key responsibilities

• Lead the development and execution of regulatory strategies for post‑approval activities and new product submissions.
• Serve as the primary regulatory expert for FDA engagements, including briefing documents and meeting preparation.
• Design and implement the regulatory roadmap for EU submissions, covering gap assessments, pediatric planning, and Marketing Authorization Applications.
• Collaborate with Medical Affairs, Clinical Development, CMC, Quality, Commercial, and Executive Leadership to align regulatory plans with business objectives.
• Guide a lean team of subject‑matter experts, ensuring high‑quality regulatory deliverables.

Required profile

• Proven senior‑level experience in regulatory strategy within biotech or biopharma, preferably with cell or gene therapies.
• Strong written and oral communication skills, with a track record of authoring regulatory briefing documents and leading health‑authority meetings.
• Experience navigating FDA processes and ICH country regulations.
• Ability to work cross‑functionally and influence executive stakeholders.

Required skills

• Regulatory strategy development
• FDA submission and interaction expertise
• EU regulatory affairs (MAA preparation, ICH guidelines)
• Gene and cell therapy regulatory knowledge

What we offer

• Opportunity to lead regulatory strategy for cutting‑edge curative therapies.
• Hybrid work model with three days onsite per week.
• Collaborative environment that values diversity and radical care.