including ability to manage competing priorities. Working knowledge of relevant FDA, EMA and ICH guidelines and regulations...
corrective and preventive actions (CAPAs) as needed. Stay up-to-date with industry regulations and standards (e.g., FDA, EMA...
, such as ICH-GCP and FDA/EMA/PMDA regulations Understanding of clinical trial processes, including study design, patient recruitment...
) as needed. Stay up-to-date with industry regulations and standards (e.g., FDA, EMA, GMP, ISO) to ensure compliance. Provide technical...
of life sciences industry dynamics, including regulatory requirements (e.g., FDA, EMA) and data standards (e.g., IDMP, ISO...
pharmacovigilance requirements and regulations (EMA, FDA, PMDA, Asia-PAC, ICH) Strong people and project management experience with the...
, document management systems, QC tools and Veeva Quality System. Expert knowledge of FDA, EMA, Asia-PAC, and ICH regulations...
diagnostics preferred Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics...
with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA...
. Ability to work well in both individual and leadership capacities Knowledge of DeltaV, cGMP, FDA/EMA regulations, Process Validation...