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...
capabilities. Preferred Qualifications: Experience supporting regulatory inspections (FDA, OSHA, EMA). Knowledge of RCM, FMEA...
to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START...
to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA approval. The START...
understanding related to drug development Knowledge of FDA, EMA, WHO, and ICH regulatory requirements Excellent laboratory...
, 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...