and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx' policies, SOP... of projects. Ensure activities and deliverables are in compliance with FDA, EMA and local regulations and guidance...
across phases. Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures...
to other staff members. Scan appropriate documents into EMA. Verify insurance benefits and eligibility. Collect outstanding...
of associated clinical trials across phases. Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity...
throughout the Chicago Eligible Metropolitan Area (EMA) Assist with program administration and meeting facilitation of the...
with regulatory requirements. Lead communications with global health authorities (FDA, EMA, etc.), including preparing... environment. Strong track record of managing relationships with health authorities, including FDA and EMA. Demonstrated success...
manufacturing facilities:The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP... client audits; Lead support of regulatory (FDA, EMA) and client audits/inspections of Catalent. Implement continuous...
. Responsible for manufacturing related regulatory compliance (FDA, EMA, IPEC, ISO, etc.), adherence to company and departmental... of regulatory compliance (FDA, EMA, IPEC, ISO, etc.) and standard operating procedures Seek out and identify opportunities...
. Experience with CDISC standards (SDTM, ADaM). Knowledge of clinical trial processes and regulatory requirements (e.g., FDA, EMA...
. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. Must be action-oriented and proficient...