. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...
. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
/EMA regulations and ICH guidelines. Provide clear and valid regulatory guidance and direction to other departments... decision by health care regulatory authorities, specifically including FDA and EMA. Knowledge and management of the regulatory...
with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support...
% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role...
of working with EMA is preferred Must have strong verbal and written communication skills Scribing experience is highly...
and familiarity with EMR systems (ModMed/EMA). Professional, detail-oriented, and compassionate toward patients...