Regulatory Strategy Leader — Gene Therapy

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

Job summary

Genetix Biotherapeutics in Somerville, MA is seeking an experienced Senior Director of Regulatory Strategy to lead regulatory strategy and health authority interactions across our gene therapy portfolio. This is a hands-on leadership role that defines strategy and executes critical regulatory deliverables.

The successful candidate will partner with Medical Affairs, Clinical Development, CMC, Quality, Commercial, and Executive Leadership to accelerate patient access to transformative therapies

Qualifications

• Advanced degree in life sciences or regulatory science is required.
• Minimum 10 years in biotech/pharma.
• Minimum 6 years in regulatory affairs/regulatory strategy.

Responsibilities

• Lead regulatory strategy and health authority interactions for gene therapies.
• Develop EU regulatory roadmap including PIPs and MAAs readiness.
• Manage global regulatory strategy and oversee submissions and intelligence.

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional leadership

Education

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

Job description

Genetix Biotherapeutics in Somerville, MA is seeking an experienced Senior Director of Regulatory Strategy to lead regulatory strategy and health authority interactions across our gene therapy portfolio. This is a hands-on leadership role that defines strategy and executes critical regulatory deliverables.

The successful candidate will partner with Medical Affairs, Clinical Development, CMC, Quality, Commercial, and Executive Leadership to accelerate patient access to transformative therapies