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...
of GMP quality systems in accordance with ICH, FDA, EMA, and other global regulatory requirements Provide quality oversight...
. Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.). Supports regulatory requests...
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...
the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200...
and familiarity with FDA, EMA, and global regulations. Strong scientific writing skills and communication skills (written and verbal...
of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) Solid knowledge and understanding of global...
(E6 R2/R3), applicable regulatory requirements (such as FDA, EMA, Health Canada, MHRA), and the sponsor’s Quality...
, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites...
regulatory requirements (FDA, MHRA, EMA), relevant industry standards, and OSHA regulations. Utilize experience and knowledge...