... and inspections to demonstrate compliance with these requirements In addition ... processes and procedures Ensures organization compliance with applicable laws and regulations ... multiple global business functions and regulatory authorities. Needs to be able ...
... biopharmaceutical products according to external regulatory requirements (e.g. USP <661> ... , ICH or other compendial or regulatory requirements Experience with polymers and ...
... components and systems, i.e. regulatory questions, support complaint investigations and ... , CCS, combination products and relevant regulatory requirements (e.g., FDA, EMA, ... , experience in authoring and reviewing regulatory submissions The candidate must be ...
... disposition with respect to the Regulatory and legal requirements (ISO 13485, ... Firm experience and knowledge in regulatory and legal requirements of medical ...
... way. You also ensure site compliance with applicable cGMP and Medical ... improve bottom-line growth Ensure compliance with safety and environmental requirements ...
... -Systemen sowie IT-Infrastruktur GMP-Compliance wünschenswert Sehr gute Deutsch- und gute Englischkenntnisse GMP-Compliance von Vorteil Ergebnisorientierte und proaktive ...
... supplies on time and in compliance with regulations. Responsibilities include preparing ... required Understanding of importance of compliance in a regulated environment Goal- ...
... needs and the impact of regulatory issues Demonstrated success in negotiation ...
... . die Tochtergesellschaft CQA, Medical Information, Regulatory Affairs und PharmacovigilanceUnterstützung von komplexeren ...
... mit verantwortlichen Fachbereichen (z.B. Regulatory Affairs, Herstellung, Analytik) Ansprechpartner für ...