Description Senior Regulatory Affairs Scientist Location: Hybrid Job Type: Full-Time About the Role Join a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products. Key Responsibilities • Develop and execute regulatory strategies and submission plans • Prepare and submit INDs, NDAs, BLAs, and IDEs • Serve as primary liaison with FDA and regulatory agencies • Provide regulatory guidance to cross-functional teams • Monitor regulatory trends and ensure compliance with evolving requirements • Review and approve regulatory documentation Requirements Qualifications • Advanced degree in regulatory science, biology, or related field • 8+ years of regulatory affairs experience • Strong knowledge of FDA regulations and ICH guidelines Preferred • RAC certification • Experience with electronic submissions (eCTD)