of regulatory requirements (FDA, EMA, ICH/GCP) and global clinical trial regulations. Excellent leadership and communication skills...
testing Deep understanding of cGMP, FDA, EMA, and ICH guidelines Demonstrated ability to troubleshoot complex analytical...
and documenting processes for solid oral dosage, API, and aseptic small molecule production to ensure compliance with FDA, EMA...
frameworks and inspection expectations (e.g., FDA, EMA, MHRA, ICH, PIC/S). Proven experience developing and maturing inspection...
of experience in a regulated industry, preferably with 2+ year of deviation experience. Experience in FDA/EMA regulations...
We have an opening for a full time FOOD SERVICE LEAD RECEIVER position. Location: UBS EMA - Cafe - 11 Madison Avenue...
of FDA, EMA, ICH, and other relevant regulatory guidance;ensure incorporation of evolving scientific standards... development. Acts as the company toxicology representative and addresses questions in interactions with FDA, EMA...
bioanalysis, and method validation. Strong knowledge of global regulatory guidance (FDA, EMA) and GLP/GCP bioanalytical...
that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators...
excellence (e.g., CLIA, CAP, GCP, ICH, FDA, EMA). Assess and report on compliance with clinical trial protocols, sponsor..., EMA), and internal audits. Coordinate timely and strategic resolution of audit findings and CAPAs, reinforcing a culture...