resolution. Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry... requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations. Prepare and contribute to regulatory submissions...
with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support...
regulatory requirements (FDA, MHRA, EMA), relevant industry standards, and OSHA regulations. Utilize experience and knowledge...
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...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200...
, and compliance requirements, including ICMJE, GPP, FDA, EMA, and internal SOPs. Maintain awareness of competitor publications... standards and compliance requirements (e.g., ICMJE, GPP, FDA, EMA). Experience collaborating cross-functionally with Clinical...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
validation documentation complies with GMP, FDA, EMA, and ICH requirements Participate in deviation investigations, CAPAs... Familiarity with biopharmaceutical or biotech manufacturing environments Experience supporting regulatory inspections (FDA, EMA...
. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA...