Senior Director of Regulatory Strategy — Gene Therapy

Genetix Biotherapeutics; Boston (MA); Hybrid; USD 265,000 - 331,000; Full time

Benefits offered by this job

Comprehensive health care

Employer-matched 401(k)

Commuter subsidy

Paid parental leave

Flexible time-off

Tuition reimbursement

Paid onsite parking

Job summary

Genetix Biotherapeutics seeks an experienced Senior Director of Regulatory Strategy to lead regulatory strategy and health authority interactions across our gene therapy portfolio. This hands-on leadership role defines strategy, executes submissions, and partners with FDA, EMA, and other regulators to accelerate patient access.

You will lead a lean regulatory team, work cross-functionally with Medical Affairs, Clinical Development, CMC, Quality, and Commercial, and drive EU readiness and

Qualifications

• Advanced degree in life sciences, pharmacy, or regulatory science.
• Minimum 10 years of biotechnology/pharmaceutical industry experience.
• Minimum 6 years of progressive regulatory affairs/regulatory strategy experience.
• Proven success with FDA interactions and major US regulatory submissions.
• Experience with EU regulatory processes is preferred.

Responsibilities

• Lead FDA engagement strategy and regulatory submissions for the portfolio.
• Develop and execute EU regulatory roadmaps including PIPs and MAAs.
• Manage Regulatory Strategy team and oversee global regulatory activities.
• Partner with Medical Affairs, Clinical Development, CMC, Quality, Commercial and Leadership.

Skills

Regulatory leadership

FDA interactions

Cross-functional leadership

Regulatory strategy

Written & verbal communication

Strategic planning

Education

Advanced degree in life sciences/regulatory science (PhD/PharmD/MD preferred)

Job description

Genetix Biotherapeutics seeks an experienced Senior Director of Regulatory Strategy to lead regulatory strategy and health authority interactions across our gene therapy portfolio. This hands-on leadership role defines strategy, executes submissions, and partners with FDA, EMA, and other regulators to accelerate patient access.

You will lead a lean regulatory team, work cross-functionally with Medical Affairs, Clinical Development, CMC, Quality, and Commercial, and drive EU readiness and