to balance costs, timelines, risks, and objectives. Direct cross-functional teams across CMC, clinical, nonclinical, regulatory...
cross-functional teams across CMC, clinical, nonclinical, regulatory, and commercial functions. Build strong partnerships...
Associate Director/ Director, CMC Regulatory Affairs Department: 58 - Tech Ops Management Employment Type: Full... based in Redwood City, CA, is looking to hire an Associate Director/Director of CMC Regulatory Affairs. Codexis...
from manufacturing, process development and CMC to clinical affairs (Clinical Operations, Biometrics, medical affairs) and non-clinical...
, Orphan Drug Designations, and expedited program applications. Collaborate cross-functionally with CMC, clinical.... Familiarity with nonclinical or CMC regulatory requirements....
, pharmacology, CMC, and clinical groups, to support data-driven decision-making. Manage bioanalytical and DMPK studies conducted...
an effective regulatory affairs cross-functional team on a dotted-line basis (CMC, Regulatory Operations, US Labeling, Promotion...
and standards, specifically CMC, OSHPD, IECC/ASHRAE 90.1, FGI/ASHRAE 170, LEED energy efficiency and indoor quality and NFPA...
dependencies among CMC, nonclinical, clinical pharmacology, clinical, and regulatory for integrated development programs... clinical, nonclinical, CMC and regulatory experience;Regulatory Affairs Certification (RAC) desired Experience with FDA...
strategy and global products (Virtual Card, vPayment, CMC) in response to a rapidly evolving virtual payments market...