requirements (e.g., FDA, EMA) and industry standards (E.g., GxP, 21 CFR Part 11) In-depth understanding of industry accepted...
timelines and regulatory requirements (e.g. ICH, FDA, EMA, pharmacopoeias) You will independently manage complex projects...
is required. Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies is required. M.Sc. or Ph.D. in Analytical Chemistry...
management tools (i.e., FMEA, risk assessments) Experience supporting regulatory inspections and audits (e.g., FDA, EMA, PIC...
and familiarity with FDA, EMA, MHRA, and other European and international regulatory requirements, guidelines...
will be a plus Preferred - Similar knowledge of EMA, Latin America and middle-east countries will be a plus - 3 - 5 years of hands... is highly desirable. - As a CMC reviewer (assessor) with FDA or EMA is highly desirable. Educational Qualifications...
regulatory guidance (FDA, EMA, ICH) on nonclinical safety requirements;proactively assess and communicate implications for AIRx... Expert knowledge of ICH guidelines, FDA and EMA non-clinical expectations, and the regulatory context governing non-clinical...
policies that satisfy both domestic and global health authority requirements including but not limited to: cGMP, FDA, EMA...
with study timelines. Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements, while maintaining...
laboratories, and service providers. Support regulatory (FDA, EMA) and internal audits/inspections per procedures and applicable...