or emerging biotech company environment. Global regulatory experience including FDA and EMA, other regions a plus. Demonstrated...
regulations (e.g., FDA, EMA, ICH). Support continuous improvement initiatives within PV operations. Facilitate the generations...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred....
activities comply with relevant regulations, ethical standards, and industry best practices (FDA, EMA, ICH-GCP) Develop..., regulatory requirements (FDA, EMA, ICH-GCP), and data governance principles Proven track record of leading transformational...
of regulatory guidelines including FDA, EMA, and ICH bioanalytical method validation guidance. Experience working in a GLP/GCP...
requirements, including FDA, EMA, and ICH. Strong understanding of analytical testing methods and laboratory operations...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...
(plan). Regulatory agency's (e.g. FDA, EMA, etc.) guidelines are followed where appropriate. All raw data, documentation...
compliance requirements (FDA, EMA). Proven ability to lead cross-functional teams, manage multiple concurrent projects...
as a Subject Matter Expert (SME) during internal audits and external regulatory inspections (e.g., FDA, EMA). Provide technical..., and regulated documentation Experience supporting FDA, EMA, or other regulatory inspections and audits Strong analytical...