with FDA, EMA, and other relevant regulatory requirements - Participate in the development of validation strategies, ensuring...
such as Modernizing Medicine (“EMAâ€). Ability to adhere to strict attendance and punctually expectations. Ability to attend...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
for individual studies and ISS/ISE to FDA, EMA, and other worldwide regulatory agencies Participate in the review of statistical...
Dermatology experience REQUIRED. At least 1 year of back office experience REQUIRED (any specialty). 3 months of EMA/Mod Med EHR... patients with results. Chart in EMA: pad and desktop. Email your resume to [email protected]...
. Knowledge and experience of the FDA, EMA, MHRA and HC regulations, quality standards and product development process such as ISO...
right first-time manufacturing in accordance with FDA/EMA/ICH regulations/guidance. Lead root cause investigations...
of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, Health Canada, MHRA...
Experience with assisting with biopsies and minor office surgeries is a plus Experience with EMA EMR system...
is required. Understanding of US and EMA labelling requirements for GRL role is preferred. In depth knowledge of current US FDA, Health Canada... (and EMA for GRL) and global regulations as they relate to overall regulatory strategy is preferred. Ability to work...