Sr. Director, Regulatory Strategy

Scorpion Therapeutics; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Genetix Biotherapeutics is seeking a Senior Director of Regulatory Strategy to lead regulatory affairs for gene therapies. You will direct global strategies and interactions with health authorities, shaping lifecycle management and major submissions.

The role requires extensive experience in regulatory affairs, with a track record of successful FDA interactions and cross-functional leadership in a fast-paced environment. Hybrid work setup in the Boston area is offered.

Qualifications

• Advanced degree in life sciences
• 10+ years industry experience, 6+ years in regulatory affairs
• Proven success in FDA interactions and major US submissions

Responsibilities

• Develop and execute global regulatory strategies for gene therapies
• Lead FDA/EMA engagements and lifecycle management
• Manage regulatory teams and external consultants

Skills

Regulatory leadership

FDA interactions

Education

Advanced degree in life sciences

Job description

Role: Senior Director of Regulatory Strategy leading regulatory affairs and health authority interactions for gene therapies at Genetix Biotherapeutics.

Responsibilities

• develop and execute global regulatory strategies, support FDA and EMA engagements, lead lifecycle management, and oversee regulatory submissions for products in clinical and post-approval stages
• partner cross-functionally with Medical Affairs, Clinical, CMC, Quality, and Commercial teams
• manage regulatory teams and external consultants

Requirements

• advanced degree in life sciences, 10+ years industry experience, 6+ years in regulatory affairs, proven success in FDA interactions and major US submissions
• experience with biologics, cell, and gene therapies
• strong regulatory knowledge including ICH countries and EU processes

Preferred

• direct gene therapy experience, BLA approval support, PIPs, and European regulatory expertise

High-Value

• focus on gene therapies, lifecycle management, FDA and EMA engagement, regulatory leadership for global product development, and strategic planning for market access

Work setup

hybrid in Somerville, MA, with candidates within commuting distance.