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...
labeling Knowledge of labeling within a Therapeutic Area Knowledge of FDA, or EMA, or other international regulations...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
Journeyman License, NACE CIP 1, 2, 3, EMA (Expediting Management Association) Basic, Advanced, ASNT NDT Level II, III, and ASQ...
two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10... with clients during initial and subsequent manufacturing campaigns; supports regulatory (FDA, EMA) and client audits/inspections...
(e.g., ISO, FDA, EMA guidelines). Quality Management System: Establish and maintain an effective quality management system... Compliance: Ensure compliance with relevant regulatory agencies (such as ISO, FDA, EMA) and applicable guidelines, including Good...
. In-depth knowledge of industry standards and regulations related to quality control. Knowledge of FDA, EMA, CFDA, PDA...
or equivalent in a Medical Device or FDA Regulated industry. Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR...
compliance with regulatory standards, including FDA, EMA, and ICH guidelines. Monitor trial progress and ensure high-quality...), and Biologics License Applications (BLA). Serve as the primary medical liaison with regulatory agencies, including the FDA, EMA...
manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP...