authorities (e.g., FDA, EMA, and other global regulatory agencies) Independently or with limited oversight, plan, compile, review... with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission Coordinate with vendors to appropriately plan...
with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards. Create and maintain standards guides... oriented, self-starter with experience in a complex manufacturing environment. Experience with FDA, EMA, and ISO regulations...
guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard...
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
and Module 3) for global marketing and post-approval applications. Strong knowledge in global regulatory (FDA, EMA...
related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND...
compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance... of interactions with Regulatory authorities worldwide (FDA, EMA etc.) at type C, B, pre-BLA/MAA/NDS meetings, Scientific Advice...
your assigned EMA/TGA. Utilizing your strong understanding of all the Ryan White Services, you will know and understand the contract... accordance with the current EMA/TGA HIV Case Management Standards. This position will work with both staff and leadership...
knowledge of the application of FDA GMP and EMA regulations. Expert in instrumentation and control panel hardware/wiring...