and IDE submissions, FDA interactions, and EMA exposure. Strong project management expertise, advanced knowledge of FDA...
from global health authorities (e.g., FDA, EMA, CFDA) and their operational implications. Excellent written and verbal...
regulations and guidance, including FDA, EMA, PMDA, NMPA, MFDS, ICH, GDPR, GAMP 5, and 21 CFR Part 11, with practical experience...
regulations (e.g., FDA, EMA, ICH). Support continuous improvement initiatives within PV operations. Facilitate the generations...
) that align with regulatory guidelines (e.g., FDA, EMA) and internal standards. Conduct statistical analyses on clinical trial... requirements (ICH GCP, FDA 21 CFR Part 11, EMA guidelines). Strong analytical skills and a meticulous approach to data handling...
software (specifically EMA/Modernizing Medicine or Nextech). Speed & Stamina: Ability to handle high patient volumes...
Operations or Clinical Research related experience. Basic understanding of FDA and EMA Regulations, ICH guidelines, GCP...
aligned with agency expectations (e.g. FDA, EMA, Health Canada, PMDA) Lead preparation and authorship of CMC sections... with global regulatory frameworks (FDA, EMA, ICH guidelines) Proven ability to operate effectively in a small, fast-paced...
biotechnology company. Ensure compliance with ICH GCP, FDA and EMA regulations, company SOPs, and applicable industry standards...
Services at a managerial level in your assigned EMA/TGA. Utilizing your strong understanding of all the Ryan White Services... are in accordance with the current EMA/TGA HIV Case Management Standards. This position will work with both staff and leadership...