rotation is 7 days per month. No on-call required for non-surgical roles. EMR System: Experience with Modernize Medicine (EMA...
of FDA, EMA PV regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global...
guidelines and requirements beyond FDA and EMA, such as those from the ASEAN countries or Latin America, Health Canada, the...
; prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks...
and/or INTERACT meetings, IND filing, Orphan Drug Designation requests, EMA submission) as necessary. Continue to support late... (e.g. pre-IND and/or INTERACT meetings, IND filing, Orphan Drug Designations requests, EMA submission) Required Skills...
, such as FDA, EMA, PICs, USP and ICH guidelines. Maintain the company's sterile manufacturing operations, including cleanroom...
, & others such as Commercial. Interpret FDA/European Medicines Agency (EMA) regulations, guidelines, policy statements, etc. for drug therapeutics... or distributed to meet relevant regulatory HA requirements; & interpreting FDA/EMA regulations, guidelines, policy statements...
into the Central Nervous System (CNS penetrant) that has received Orphan Medicinal Product Designation from the EMA... Authorization Application (MAA) has been validated and is currently being reviewed by the EMA's Committee for Medicinal Products...
into the Central Nervous System (CNS penetrant) that has received Orphan Medicinal Product Designation from the EMA... Authorization Application (MAA) has been validated and is currently being reviewed by the EMA's Committee for Medicinal Products...
Application (MAA) is currently under review by the European Medicines Agency (EMA). Menarini’s commitment to oncology...