Assoc. Director, Regulatory Affairs Strategy

Role: Associate Director, Regulatory Affairs Strategy at BioCryst, focusing on developing and executing global regulatory strategies for biotech/pharmaceutical products in rare diseases. Responsibilities: manage initial and post-approval global regulatory activities, prepare and submit INDs, BLAs/NDA filings, support lifecycle management, lead or support global regulatory submissions, serve as Regulatory Lead on projects, facilitate health authority interactions, and ensure compliance with global regulations. Requirements: Bachelor's degree (advanced degree preferred), 8-10 years regulatory strategy experience in biotech/pharma, strong knowledge of US FDA regulations, global regulatory experience a plus, excellent organizational, communication, and cross-functional collaboration skills. HighValue: experience with INDs, BLAs/NDA, lifecycle management, global regulatory submissions, and interaction with health authorities. WorkSetup: not specified.