of acceptability of data to the FDA, EMA and / or clients. This role has high impact on site performance in terms of compliance...
regulatory and quality standards (FDA, EMA, ICH) and are in a state of control throughout their lifecycle. The ideal candidate... with cGMP, FDA, EMA, ICH, and other applicable regulatory guidelines. Support inspection readiness and represent CQV function...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...
through development, database lock, and reporting/submission. Deep understanding of ICH-GCP, FDA, EMA, and other global...
under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded...
use Modernizing Medicine - EMA) Maintain adaptable and functional computer skills Respond to emergency situations based..., required SECTION 4: Knowledge, Skills and Abilities Requirements Thorough knowledge of medical terminology - required Prior EMA...
of testing services, adherence to regulatory standards (FDA, EMA, ICH), and effective communication with internal teams...
Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...