Senior Director, Program Management, Regulatory Affairs

We are a pioneering company developing a gene therapy for rare pediatric neurodegenerative disease. We have a program in registrational studies and have just kicked off their BLA process. We need a skilled Regulatory professional to drive the planning, coordination, and execution of regulatory activities supporting our gene therapy pipeline.

What You Will Do

The role ensures that regulatory submissions and health authority interactions are delivered on time, to a high standard, and in alignment with program strategy.

Why It Might Be a Fit

This role sits at the intersection of Regulatory Affairs, CMC, Clinical, Nonclinical, and Quality, requiring a strong sense of purpose, innovation, and creative problem-solving.

Requirements

• skilled Regulatory professional
• experience in regulatory activities supporting a gene therapy pipeline
• ability to drive planning, coordination, and execution of regulatory activities