guidelines including regulatory initiatives/actions from ICH, FDA, EMA and other countries as appropriate. Enhances regulatory...
more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START...
—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs...
1, Ph 2 and Ph 3). Seek input from regulators through EMA | HTA joint scientific advice to inform an asset...
and major regulatory interactions, and represent Biostatistics in engagements with global regulatory authorities (e.g., FDA, EMA...) and interactions with health authorities such as FDA, EMA, and PMDA. Experience with people management, particularly in developing...
and international PV regulations (e.g., FDA, EMA, ICH). Safety lead/co-lead contribution in establishing and maintaining robust safety... of existing/current global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH Demonstrable understanding...
, including having played a lead role in more than one IND/IMPD, BLA/NDA/MAA filing and in Advisory Committee or other PMDA/EMA... major regulatory filings – IND/IMPD, BLA/NDA/MAA. Experience leading preparation of PMDA/EMA/FDA milestone meetings...
and compliance with applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA). This role supports clinical trial teams by managing...
expectations (FDA, EMA) for aseptic manufacturing Proven experience in process validation (PPQ) and lifecycle management...
that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators...