and maintenance of documentation best practices. Stay up-to-date with industry regulations and guidelines (e.g., FDA, EMA...
regulatory inspections of facilities from major agencies such as FDA or EMA. Strong change management skills, adaptability...
equipment, RPC, EMA, etc. This includes specification of equipment, CER preparation, installation, and validation of test... handling analysis. · Experienced in Ride and Handling experimental development, EMA and forced response analysis...
technologies and formulation processes, preparing development plans, and ensuring compliance with cGMP, FDA, and EMA regulations... production. Ensure compliance with cGMP, GLP, GCP, FDA, and EMA guidelines. Identify and support initiation of Deviations...
, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP...
’ strategic objectives and in accordance with FDA, EMA, GCP, and ICH guidelines. This role is responsible for collaborative...
compliance with global regulations (FDA, EMA, NMPA, etc.). Oversee signal detection, risk assessment, and mitigation activities... safety regulations and guidelines (FDA, EMA, ICH, NMPA). Strong leadership and strategic thinking capabilities. Exceptional...
of successful submissions and interactions with regulatory agencies (e.g., FDA, EMA, etc.). Strong understanding of global regulatory...
(e.g., FDA, EMA, ISO). Review validation documentation for completeness and compliance. Documentation and Reporting...
regulatory standards such as FDA, EMA, and GxP guidelines. This ensures that the applications are reliable, secure, and compliant...