. Knowledge of relevant FDA and EMA regulations. Ability and willingness to work in a fast-paced environment that will require...
with global regulatory expectations (FDA, EMA, ISO 11607, USP). Prepare and review packaging documentation for regulatory...
with global regulatory expectations (FDA, EMA, ISO 11607, USP). Prepare and review packaging documentation for regulatory... expectations (FDA, EMA, ISO 11607, USP). Prepare and review packaging documentation for regulatory submissions. Support tech...
requirements and translate them into SAP solutions aligned with GxP and regulatory standards. Ensure compliance with FDA, EMA...
requirements and translate them into SAP solutions aligned with GxP and regulatory standards. Ensure compliance with FDA, EMA...
), FDA/EMA regulations and will involve collaboration with cross-functional teams to maintain BioMarin's commitment... document control system in accordance with FDA, EMA, and other regulatory agency requirements, ensuring that all quality...
management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory...