Senior Director of Regulatory Affairs

Job Summary

To advance precision psychiatry, the full-time Senior Director of Regulatory Affairs will develop and execute global regulatory strategies for neuroscience programs, serving as the primary regulatory liaison with health authorities while ensuring timely and efficient development from IND through approval.

Key responsibilities

• Lead global regulatory strategy for assigned programs, including interactions with FDA, EMA, and other health authorities
• Oversee the planning, content, and quality of regulatory submissions and maintain compliance within the Regulatory Information Management system
• Provide functional leadership across programs, representing regulatory strategy in cross-functional teams and governance discussions

Required qualifications

• Advanced degree in a scientific, medical, or health-related discipline (PhD, PharmD, MD, or MS with extensive experience)
• 15+ years of progressive regulatory affairs experience in biotech or pharma, including leading global regulatory strategy
• Demonstrated success in health authority interactions and securing expedited designations
• Direct experience as regulatory lead on IND/CTA through NDA/BLA/MAA programs
• Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements