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...
of regulatory guidelines including FDA, EMA, and ICH bioanalytical method validation guidance. Experience working in a GLP/GCP...
is required. Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is required. M.Sc. or Ph.D. in Analytical Chemistry...
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...
timelines and regulatory requirements (e.g. ICH, FDA, EMA, pharmacopoeias) You will independently manage complex projects...
requirements, including FDA, EMA, and ICH. Strong understanding of analytical testing methods and laboratory operations...
preferred Experience utilizing Modernizing Medicine / EMA Electronic Medical Record (EMR) highly preferred....
to date knowledge of and compliance with government regulations (e.g., FDA, EMA, MHRA, OSHA, DEA, etc.), industry standards (e.g., WHO...
standards (SDTM, ADaM) Experience supporting regulatory submissions (e.g., FDA, EMA) Skills/Knowledge/Abilities: Expert... with multiple regulatory submissions (e.g., FDA, EMA). Leads programming procedural documents (SOPs, work instructions and job aids...
. Additional Qualifications Has thorough understanding of global health authority regulations including FDA and EMA. Possesses...