BA/BS with 6+ years of experience, or MBA/MS with 5 + years of experience, or PhD/JD with 1+ years of experience, or MD/DVM with 0+ years of experience., Extensive knowledge in drug development, Regulatory Affairs, and submission management., Advanced Microsoft Office Suite skills and strong competency with tools., Strong understanding of regulatory submission processes and requirements., Excellent analytical and problem-solving abilities., Effective communication skills, both written and verbal., Bonus Points If You Have (Preferred Requirements), Experience in the pharmaceutical or biotechnology industry with advanced knowledge of regulatory guidelines and compliance standards., Strong understanding of statistical modeling and data analytic methodologies., Demonstrated knowledge of product lines, processes, and associated technologies., Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance