to pipeline products. Maintain an up-to-date awareness of regulatory (e.g. FDA, EMA) and payer/HTA considerations that may impact... and conduct of HEOR studies and models. Solid understanding of regulatory (e.g. FDA, EMA) and HTA considerations. Experience...
knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing...
and approve data flows, interfaces, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal...
plus 10+ years of experience, 7 of which should be in a management role Knowledge of FDA, EMA, CFDA, PDA Regulations...
regulatory standards (FDA, EMA, ICH). Procedure Development: Author, review, and approve SOPs, work instructions, and technical...
, and integrations between systems. Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems...
leadership experience in a pharmaceutical or biotechnology industry and regulatory submissions and interactions (i.e. FDA, EMA... to date knowledge of GCP, ICH, US FDA and EMA regulations Able to effectively partner with Global Program Head and Program Strategy...
or life sciences systems and regulatory compliance frameworks (GxP, FDA, EMA). Preferred Experience and Education...
guidelines (e.g., FDA, EMA). Experience working with external partners and managing collaborative projects. Required Skills...
for global health authorities (FDA, EMA, PMDA), serving as the author for complex submissions Author and oversee critical...