and compliance of products. Create high-level reports and new documentation including envelope drawings, Schematic, EMA Fabrication..., and EMA design, as well as managing full BOMs of different part numbers. Perform failure analysis and identification of root...
: Understanding of cGMP and Quality systems;familiarity with FDA/EMA guidance relevant to gene and cell therapy;experience...
. Strong working knowledge of regulated environments and regulatory expectations/compliance frameworks (e.g., cGMP, FDA, EMA...
and compliance with applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA). This role supports clinical trial teams by managing...
working with international regulatory frameworks (e.g., EMA, PMDA, Health Canada) preferred. Prior exposure to medical device...
Educational Records Bureau (ERB) and the Enrollment Management Association (EMA), E3n builds on nearly a century of collective...
and limitations. Knowledge of endpoint validation frameworks and regulatory requirements (e.g., FDA/EMA). Experience working...
, but not limited to, FACT, JACIE, FDA, HTA, HealthCanada and EMA Advanced communication skills, with the ability to influence...
goals and ensure high performance. Oversee daily aseptic manufacturing operations, ensuring compliance with FDA, EMA...
(EMA), other applicable jurisdictional authority) and audits of the Foundation. Validation Execution and Documentation...