collaboration Familiarity with FDA, EMA, and ICH regulatory expectations for gene therapy potency strategy Strong statistical...
FDA, EMA, or other regulatory authority inspections. Demonstrated leadership, interpersonal, communication...
) and writing regulatory documents (IND, BLA). Knows global regulations (FDA, EMA, ICH) and works well in fast-paced teams...
with an EMA electronic system designed to streamline documentation and improve workflow. Compensation & Benefits Competitive...
, such as FDA, EMA, MHRA, PIC/S, ICH, and sterility assurance standards. Experience working with third-party manufacturers...
Support Inspection readiness programs across the organization. Regulatory agency inspections (e.g., FDA, EMA...
Support Inspection readiness programs across the organization. Regulatory agency inspections (e.g., FDA, EMA...
knowledge of FDA and EMA regulations, including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR. Broad...
, 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 operational purposes. Knowledge of FDA/EMA digital health technology, patient focused drug development, and endpoint guidance...