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...
of all interactions with patients via EMA. 5. Speaks with patients or patient representatives to give biopsy and lab results. 6. Obtains...
knowledge of the application of FDA GMP and EMA regulations. Expert in electrical power supply and distribution. Experience...
: Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines This job posting...