of supply chain activities, ensuring adherence to regulatory guidelines (e.g., FDA, EMA, ICH, GCP). Support Investigational...
properties and support IND submission. Develop study designs aligned with FDA/EMA guidance for IND-enabling packages, including...
guidelines (e.g., FDA, EMA). Experience working with external partners and managing collaborative projects. Required Skills...
in new facility start-up or tech transfer projects Expertise in global regulatory requirements (FDA, EMA...
comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides. Interpret and present...
manufacturing;gene therapy experience highly desirable. Strong knowledge of cGMP, FDA, and EMA regulations. Proficiency in ERP...
/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus Attributes...
Knowledge and experience with FDA and EMA regulatory CMC requirements Demonstrated ability to influence internal and external...
and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively...
regulatory requirements (FDA, EMA, WHO, Annex 15, ISO, etc.) related to commissioning, qualification and validation...