This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Regulatory Affairs based in the United States.

This is a strategic regulatory leadership opportunity within a clinical-stage biotechnology environment focused on transformative gene therapies.
The role will shape global regulatory strategy for assigned development programs and provide critical guidance across preclinical and clinical development.
You will work closely with multidisciplinary teams spanning Clinical, CMC, Quality, Medical, Nonclinical, and Project Management.
The position offers significant exposure to U.S., European, and other global health authorities, including opportunities to lead agency interactions.
You will help drive high-quality regulatory submissions, development strategies, designations, and health authority communications.
Success will require strong scientific judgment, strategic thinking, and the ability to translate complex regulatory considerations into clear recommendations.
This fully remote U.S.-based role is ideal for a seasoned regulatory professional motivated by advancing innovative therapies for patients with serious diseases.

What the job really is