or GCP also valued). Experience supporting regulatory inspections or audits (e.g., FDA, EMA). Knowledge of AI/ML systems...
, and housekeeping. Leadership in the area of manufacturing-related compliance (FDA, EMA, IPEC, ISO, etc.). Deliver results according...
, author study reports and review technical section summaries for submission to regulatory agencies (FDA, EMA, EPA). Lead... studies. Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA for product registration...
and ISO regulated environments Knowledgeable in technical guidance documents from FDA, EMA, PDA, ISPE, ICH, ISO, PIC...
is strongly preferred (FDA, EMA etc) Exceptional interpersonal and communication skills, with the ability to build...
, such as FDA, EMA, MHRA, PIC/S, ICH, and sterility assurance standards. Experience working with third-party manufacturers...
authorities is strongly preferred (FDA, EMA etc.) Exceptional interpersonal and communication skills, with the ability to build...
, FDA/EMA and other applicable global health authority regulations, Good Pharmacovigilance Practices (GVP), and Ultragenyx...
and manage client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health... EMA regulations, as applicable to automated business processes Data Integrity including ALCOA+ Experience...
alignment on CQV activities and project timelines. Ensure compliance with regulatory requirements (FDA, EMA...