Director/Senior Director, Regulatory Affairs Strategy

Oruka Therapeutics is seeking a Director/Senior Director, Regulatory Affairs Strategy to serve as the Global Regulatory Lead for one or more development programs and define and execute regulatory strategies that support rapid, high-quality global development of Oruka’s biologics portfolio.

Requirements

• 10+ years of progressive Regulatory Affairs experience in biotechnology or pharmaceuticals
• Strong experience developing and executing global regulatory strategy for drugs and/or biologics in clinical development
• Direct experience authoring and/or leading major regulatory submissions and briefing packages
• Demonstrated experience leading interactions with FDA and international health authorities
• Experience in dermatology, immunology, or inflammation considered advantageous

Benefits

• Competitive salary
• Equity
• Performance-related bonus opportunity
• Opportunities for professional growth and development
• Supportive and inclusive team environment
• Chance to be part of a vibrant startup culture