Senior Manager, Contractor, of Compliance and Drug Safety and Pharmacovigilance Operations
audits including USA/MHRA/EMA PV inspections....
audits including USA/MHRA/EMA PV inspections....
and effectively. In-depth knowledge of FDA, EMA, and ICH regulations for GMP compliance is essential. Responsibilities Assess... expectations. Support internal and external audits, prepare documentation, and ensure adherence to FDA, EMA, and ICH guidelines...
processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams...
skills Must have experience with EMR;Knowledge of EMA highly preferred Must be a strong and fast at typing...
with FDA, EMA, and related regulations. Develop/improve standard operating procedures (SOPs), work instructions, and quality... of cGMP, FDA, EMA, and USP guidelines relevant to packaging and labeling, and experience filing label artwork changes...
FDA & EMA regulations, ICH guidelines, GCP, and GMP. Experience with clinical logistics and pharmaceutical supply chain...
processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams...
processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams...
processes, ensures compliance with regulatory standards (such as FDA, EMA), and collaborates with cross-functional teams...
exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing. Experience working with investigational...