The Senior Regulatory Affairs Scientist role is a full-time, hybrid position focused on leading regulatory strategies for innovative medical products.
Key responsibilities include developing and executing submission plans, preparing INDs, NDAs, BLAs, and IDEs, and serving as the primary liaison with FDA and other regulatory agencies.
The role involves providing regulatory guidance to cross-functional teams, monitoring regulatory trends, ensuring compliance, and reviewing regulatory documentation.
Qualifications require an advanced degree in regulatory science, biology, or related fields, with 8+ years of regulatory experience and strong knowledge of FDA regulations and ICH guidelines.
Preferred candidates may hold RAC certification and have experience with electronic submissions (eCTD).