- Sumitomo Pharma (Denver, CO)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and...is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will… more
- University of Colorado (Aurora, CO)
- …trends and opportunities for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are ... fit for use. + Performs review of cell and gene therapy product files and sponsor protocols, ensuring accurate...- four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory.… more
- Sumitomo Pharma (Denver, CO)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of… more