Director, Product Pod Lead
Part 11, GAMP 5, GDPR, FDA/EMA guidelines). Manage and mentor a team of senior product managers, business analysts...
Part 11, GAMP 5, GDPR, FDA/EMA guidelines). Manage and mentor a team of senior product managers, business analysts...
and managing a primarily volunteer team to support and provide Partner and Emergency Management Agency (EMA) Support in an New York... State. The State Relations Disaster Liaison serves as the lead functional expert in a Red Cross Region for Partner/EMA...
(s) globally (US, EMA, Japan, Australia, Canada). This role leads the Global Regulatory Team. Serves as the primary regulatory...
on mapping studies and validation results. Regulatory Compliance: Ensures all activities comply with FDA, EMA, ICH, and ISO...
departments as well as external CDMOs. Understanding related industry guidance's (FDA, PDA, ICH and BPOG), knowledge of FDA, EMA...
, study budgets, and project timelines. Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements. Excellent...
post graduate experience). Demonstrated experience of preparing US FDA/EU EMA submissions (eg, IND/NDA/IDE/510(K)/PMA/BLA...
working with cross-functional review committees in a regulated environment. Global regulatory knowledge (EMA, Health Canada...
regulatory inspections (FDA, EMA, or equivalent) or audits related to deviations, CAPA, and change control. Other Information...
demand Modern, efficient clinic utilizing EMA / EMR software Dedicated clinical and administrative support staff allowing...