, quality, FDA and EMA regulations, technical transfer, process development, and validation. Skilled in improving productivity...
support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe...
, ICH guidelines, and regulatory requirements (FDA, EMA) Understanding of clinical trial processes and adverse event reporting...
data Develop and validate SDTM and/or ADaM datasets Support regulatory submissions (FDA/EMA) with compliant datasets...
inspections across multiple regions including FDA, EMA, and other agencies Experience building or scaling Clinical Quality...
, commercial, HMO) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the...
(FDA & EMA), regulatory authorities communication and filing documentation. Fluent in English, intermediate to full...
(IND) applications and clinical trial protocols. Ensure compliance with regulatory standards (FDA, EMA, etc.) during the...
. Ensure all deliverables meet quality standards and comply with regulatory requirements such as ICH-GCP, FDA, and EMA...
guidelines (FDA, EMA, ICH), Good Clinical Practice (GCP), and global health authority requirements for clinical trials...