Roy Kim

-Developed and implemented comprehensive CMC regulatory strategies, including preparation and review of eCTD CMC sections for assigned projects, leading to timely and high-quality global submissions for market and post-approval applications. -Expertly managed submission documents, tracked registrations, and updated Clinical Supply Shelf life using Veeva Vault Regulatory Information Management System (RIMS). -Collaborated with CMC Writing, Regulatory Operations, and Submission Project management teams to enhance internal processes and improve the CMC content in regulatory documents. -Utilized tools like Excel, Miro, MS project, and Smartsheet to improve processes within the International Regulatory Affairs organization after identifying areas for improvement. -Maintained knowledge of regulatory trends and requirements in assigned regions.

-Performed adverse events reporting functions for COVID-19 vaccines through the Vaccine Adverse Events Reporting System (VAERS) -Conducted Drug Utilization Review to reduce medication errors -Provided direct supervision of pharmacy services representatives, pharmacy technicians, and pharmacy support specialists performing pharmacy related duties -Consulted with patients and prescribers as required or necessary about drug interactions, side effects, medication storage, and other requested or pertinent prescription drug information

-Managed all associate relations functions for pharmacy staffs such as hiring, terminating, and performance management -Maintained and executed all established procedures concerning quality improvement, security of controlled substances, and record keeping -Created educational content surrounding complex topics by breaking them down into digestible formats for various audiences -Initialized Durable Medical Equipment business and successfully billed more than 200 claims to Medicare and Medicaid