Senior Director, Global Regulatory Strategy

Regulatory Jobs; Somerville (MA); Hybrid; USD 265,000 - 331,000; Full time

Job summary

Genetix Biotherapeutics is seeking a Senior Director of Regulatory Strategy to lead regulatory strategy and health authority interactions across our gene therapy portfolio. This hands-on leadership role will shape strategy and execute critical regulatory deliverables with FDA and global partners.

The successful candidate will work closely with Medical Affairs, Clinical Development, CMC, Quality, and Commercial teams to accelerate patient access while ensuring regulatory excellence.

Qualifications

• 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.
• Strong written, verbal, and presentation skills; demonstrated ability to influence senior leaders.

Responsibilities

• Lead regulatory strategy for post-approval lifecycle, label expansions, and new indications.
• Prepare for FDA interactions and cross-functional meetings with leadership.
• Develop EU regulatory roadmap, PIPs, and MAA readiness.
• Oversee global regulatory strategy and regulatory intelligence activities.
• Mentor regulatory professionals and partner with Executive Leadership.

Skills

Regulatory strategy

FDA/EMA experience

Leadership

Cross-functional collaboration

Strategic planning

Education

PhD/PharmD/MD or equivalent

Job description

Genetix Biotherapeutics is seeking a Senior Director of Regulatory Strategy to lead regulatory strategy and health authority interactions across our gene therapy portfolio. This hands-on leadership role will shape strategy and execute critical regulatory deliverables with FDA and global partners.

The successful candidate will work closely with Medical Affairs, Clinical Development, CMC, Quality, and Commercial teams to accelerate patient access while ensuring regulatory excellence.