any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...
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...
. Demonstrated working experience in regulatory submissions Familiarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred....
requirements, including FDA, EMA, and ICH. Strong understanding of analytical testing methods and laboratory operations...
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...
Compliance FDA, EMA, ISPE, ICH Guidelines URS, FDS, DDS Documentation Change Control Management FAT / SAT Execution Risk...
. Experience with FDA, EMA, ICH Q8-Q11, and ISPE guidelines. Proven background supporting greenfield or site expansion projects...
with GMP’s, FDA, MHRA, EMA and other regulatory agency requirements for pharmaceutical validation and operations, analytical...
, EMA, ICH, etc.). Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data...