Senior Director, Regulatory Affairs

This role is for a Senior Director of Regulatory Affairs to lead global regulatory strategies for a novel therapy focused on treating severe autoimmune diseases. The position involves collaborating with cross-functional teams, preparing regulatory submissions, liaising with Health Authorities, and ensuring compliance. The organization is seeking to join a growing team and help elevate the quality of care for patients with autoimmune diseases.

Requirements

• Bachelor's degree and a minimum of 10 years of direct experience in Regulatory Affairs
• Expert understanding of US and international regulations
• Preparation of nonclinical and clinical sections of regulatory filings
• Strong interpersonal and communication skills
• Leadership and problem-solving abilities
• Project management skills
• Ability to work in a fast-paced environment