Director, Business Development
% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role...
% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...
years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...
with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support...
of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) Solid knowledge and understanding of global...
and regulations and procedures preferred. Knowledge of submission requirements of various markets such as USFDA, EMA etc. an advantage..., we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
of working with EMA is preferred Must have strong verbal and written communication skills Scribing experience is highly...
& Validation Documentation Ensure all CQV documentation complies with GMP, FDA, EMA, and ICH requirements Author and review... management systems (BMS) Experience supporting regulatory inspections (FDA, EMA) Experience on greenfield or large capital...