Associate Director, Corporate Biosafety Officer
manufacturing authorities (FDA, EMA, MHRA, DMA) Proven experience as a biosafety officer in GMP environments handling recombinant...
manufacturing authorities (FDA, EMA, MHRA, DMA) Proven experience as a biosafety officer in GMP environments handling recombinant...
are not an exhaustive list; EMA would be happy to discuss a customized position based on your background and interests and the needs of the...
, MAAs, responses, variations, and briefing documents). Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations...
per month. No on-call required for non-surgical roles. EMR System: Modernize Medicine (EMA) experience preferred but not required....
understanding of FDA and EMA regulations, Good Clinical Practice, ICH guidelines, and clinical drug development Strong eye...
-solving skills Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable...
requirements throughout the lifecycle of each product. Serve as the primary liaison with regulatory agencies (FDA, EMA... collaboration and team leadership. In-depth understanding of global regulatory standards and processes (e.g., FDA, EMA...
for influencing the regulatory environment Key Skills: Knowledgeable in ICH, FDA and EMA guidelines, and familiarity with GCP..., GLP, GRP Extensive experience in working with regulatory health authorities such as FDA, EMA, Health Canada...
of all interactions with patients via EMA. 5. Speaks with patients or patient representatives to give biopsy and lab results. 6. Obtains...
trial results and scientific insights. Support regulatory submissions and communications with the FDA, EMA... and contributing to IND/NDA submissions, highly preferred. Strong understanding of GCP, FDA, and EMA regulations related to oncology...